Reported trial results for Osteoporosis

108 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT02916862 · results posted 29 October 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 177 people across four groups. Participants were given one of four combinations: a dietary fibre called Soluble Corn Fiber (SCF) together with calcium, SCF without calcium, a placebo (an inactive substitute) with calcium, or a placebo without calcium. The trial ran for 12 months and was measuring changes in bone mineral content — essentially, the amount of mineral (mainly calcium) stored in bones — across the whole body and in the spine specifically. Bone scans were taken at the start and again after 12 months using a type of low-dose X-ray scanner. The reported data shows the following changes in whole-body bone mineral content over the 12 months (measured in grams): the SCF plus calcium group showed a change of 20.1 grams; the SCF without calcium group showed 18.6 grams; the placebo group showed 17.3 grams; and the placebo plus calcium group showed 20.7 grams. For the spine specifically, the reported changes were: SCF plus calcium, 21.8 grams; SCF without calcium, 18.7 grams; placebo, 22.4 grams; and placebo plus calcium, 23.8 grams. These numbers reflect the average change within each group as submitted to the registry. It is worth noting that 151 out of the 177 participants completed the study, with between 5 and 9 people in each group not finishing. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04079868 · results posted 14 October 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04079868) looked at a "Bone Health Service" — a structured program to identify and manage low bone density (osteoporosis) in men — compared with usual medical care. A total of 1,888 men were enrolled in the Bone Health Service arm and 1,624 in the usual care arm. The trial measured things like how many men received a bone density scan (called a DXA scan), what their bone density scores looked like, and whether they were prescribed and stayed on bone-related medications. The reported data shows that in the Bone Health Service group, 830 men received a DXA bone density scan, compared with 33 men in the usual care group. Among a smaller randomly selected subgroup, the average bone density T-score (a number that compares a person's bone density to that of a young healthy adult — lower scores mean lower bone density) was −0.55 in the Bone Health Service arm and −0.70 in the usual care arm. For medications: 113 participants in the Bone Health Service arm were reported as starting osteoporosis medication, versus 4 in the usual care arm. The reported data shows that among those who were prescribed osteoporosis medication, participants in the Bone Health Service arm took their medication on about 92% of days on average, while those in the usual care arm covered 100% of days — though the trial notes that very few people in the usual care arm were on these medicines at all. The average number of days participants stayed on their medication before a gap of 90 days or more was 657 days in the Bone Health Service arm and 730 days in the usual care arm. As a measure of potential side effects from treatment, 562 people in the Bone Health Service arm and 473 in the usual care arm were reported as receiving a new prescription for a stomach-protecting medicine (such as a proton pump inhibitor). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05338086 · results posted 21 March 2025

  According to the results reported on ClinicalTrials.gov, this trial compared a medicine called MB09 — a proposed biosimilar (a near-identical copy of an existing medicine) — against an already-approved medicine called EU-Prolia (denosumab), which is used to treat osteoporosis in postmenopausal women. Osteoporosis is a condition where bones become weaker and more likely to break. The trial enrolled 281 people into the MB09 group and 277 into the EU-Prolia group during its main 12-month phase. A smaller follow-on period ran from months 12 to 18, where participants were reassigned into three groups totalling around 497 people. The main thing being measured was the change in bone density in the lower spine (lumbar spine) after 52 weeks, assessed using a special type of X-ray scan called a DXA scan. The reported data shows that, after 12 months, lumbar spine bone density had increased from its starting point by an average of 5.86% in the MB09 group and 5.66% in the EU-Prolia group (in the primary analysis group). A separate supporting analysis reported increases of 5.40% for MB09 and 5.38% for EU-Prolia. The reported data also shows changes at six months and at the hip and femur neck (the top of the thigh bone): at six months, lumbar spine bone density rose approximately 3.37% (MB09) and 3.28% (EU-Prolia); total hip bone density rose approximately 2.75% (MB09) and 2.39% (EU-Prolia) at six months, and approximately 4.03% (MB09) and 3.96% (EU-Prolia) at twelve months; femur neck bone density rose approximately 2.29% (MB09) and 2.46% (EU-Prolia) at six months, and approximately 2.18% (MB09) and 1.93% (EU-Prolia) at twelve months. The trial also measured a bone-breakdown marker in the blood called sCTX, which can indicate how quickly bone is being broken down. The reported data shows that the overall level of this marker over the first six months (expressed as an area under the curve, meaning a combined measure across the whole time period) was 12,300 day×pg/mL for MB09 and 12,400 day×pg/mL for EU-Prolia; a related measure of how much this marker was reduced from its starting level showed values of 15,100 and 15,300 (in day×% units) for MB09 and EU-Prolia respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05067335 · results posted 5 December 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 327 participants in total. During the first six months (the "double-blind" phase, where neither participants nor researchers knew who received which treatment), 109 people received a placebo (an inactive injection) and 218 received the study drug, romosozumab. After six months, the trial moved into an open-label phase — where everyone knew what was being given — and all remaining participants received romosozumab for a further six months. The trial was measuring changes in bone mineral density (BMD, a measure of how dense and strong bones are) at several sites in the body, as well as tracking how many participants experienced any unwanted medical events during the study. The reported data shows that after six months, the average change in spinal bone density was approximately +0.44% in the placebo group and +9.81% in the romosozumab group. At the hip, the reported changes were +0.07% (placebo) and +2.93% (romosozumab), and at the femoral neck (the top of the thigh bone near the hip), the figures were −0.15% (placebo) and +3.33% (romosozumab). By the end of the full 12 months, participants who had received placebo first and then switched to romosozumab showed an average spinal bone density change of +8.80%, while those who received romosozumab for the entire 12 months showed a change of +13.04%. Regarding unwanted medical events during the double-blind period, the reported data shows that 70.6% of placebo participants and 72.9% of romosozumab participants experienced at least one such event. Over the full study period, this figure was 80.6% for those who switched from placebo to romosozumab, and 88.1% for those who received romosozumab throughout. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04431960 · results posted 21 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04431960) involved 51 people in total, split across three groups: a "Low-BC" group (17 people), a "High-BC" group (16 people), and a Control group (18 people). Not everyone finished the trial — 16, 11, and 13 people completed it in each group respectively. The trial was measuring changes in bone mineral density (a measure of how dense or strong bones are) and several markers in the blood that are linked to bone health and inflammation. The groups appear to differ by the level of something referred to as "BC," though the data submitted does not spell out what the intervention was in detail. The reported data shows that whole-body bone mineral density (measured in grams per square centimetre) was similar across all three groups at both time points measured. The Low-BC group recorded 1.14 at both time points; the High-BC group went from 1.15 to 1.17; and the Control group went from 1.17 to 1.16. For the blood marker linked to bone formation (called P1NP, measured in ng/mL), the reported figures show the High-BC group's reading rose from 21.21 to 41.79, while the Low-BC group stayed relatively steady (26.55 to 25.99) and the Control group went from 32.53 to 26.36. For the bone metabolism regulator RANKL (measured in pg/mL), the High-BC group's reading fell from 133.99 to 102.09, while the Control group's rose from 256.81 to 284.47 and the Low-BC group stayed relatively stable. The inflammatory marker IL-1B showed only small numerical differences across all groups at both time points. Two additional outcomes — gut microbial composition and a blood inflammation marker (hs-CRP) — were listed as planned measurements, but no results data was reported for these in the submitted records. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05326815 · results posted 24 September 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 54 participants, all of whom had osteopenia (lower than normal bone density) and had not previously received medical treatment for it. Of those 54 people, 40 completed the study, while 14 did not finish. The trial was measuring how well different methods of testing a bone marker called NTX (a substance found in urine or blood that can reflect how quickly bone is breaking down) agreed with one another. The reported data shows one primary outcome result: a correlation value of 0.52 between the different NTX measurements. A correlation value (sometimes called an "r-value") is a number between -1 and 1 that describes how closely two sets of measurements move together — a value of 1 would mean they match perfectly, and 0 would mean no relationship at all. An r-value of 0.52 sits in the moderate range, meaning the different NTX measures showed some, but not complete, agreement with each other. No secondary outcome results appear to have been reported in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02753283 · results posted 19 September 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 201 participants in total — 62 women and 40 men received denosumab (an injectable medicine), while 61 women and 38 men received a placebo (an inactive substitute). All participants had type 2 diabetes and the trial ran for 24 months. The study was measuring changes in bone density — essentially how dense and strong bones are — at several sites in the body, using a type of low-dose X-ray scan. Not everyone finished the trial: around 17–18 women and 11–12 men in each group did not complete it. The reported data shows the following changes in bone density over the 24 months. For hip bone density (the main thing being measured), women who received denosumab showed an average increase of about 4.6%, compared with a slight decrease of about 0.2% in women who received the placebo. Men on denosumab showed an average increase of about 3.7%, compared with a smaller increase of about 0.5% in men on the placebo. For spine bone density (also a main measure), women on denosumab showed an average increase of about 7.4% versus about 2.2% in the placebo group; men on denosumab showed about 7.9% versus about 1.1% in the placebo group. Secondary measures — including bone density at the wrist and the top of the thigh bone, as well as a bone quality score called the Trabecular Bone Score (a measure of the internal structure of bone) — also showed percentage changes across the groups, generally in similar patterns, though the Trabecular Bone Score results were more variable between groups. The reported data also includes a blood marker called CTX, which reflects how quickly the body is breaking down bone. Small reductions in this marker were recorded across all four groups, with larger reductions seen in both denosumab groups compared with their respective placebo groups. These numbers are averages across the study participants and individual results would vary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03164928 · results posted 19 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03164928) enrolled 24 participants in total — 16 in the group that received denosumab throughout the study (called "Denosumab/Denosumab") and 8 in the group that started on a placebo (an inactive treatment) before switching to denosumab (called "Placebo/Denosumab"). Almost all participants finished the study — 15 out of 16 in the first group and all 8 in the second group. The trial was measuring changes in bone mineral density (BMD) — a measure of how dense or strong bones are — at the lower spine (lumbar spine) and upper leg/hip area (proximal femur), using a type of scan called DXA. It also tracked bone fractures over time. The reported data shows that bone density results were expressed as "z-scores," which are simply a way of comparing a person's bone density to the average for people of a similar age and background — a score of 0 means exactly average, and positive numbers mean above average. For the primary outcome, the lumbar spine z-score change from the start of the trial to 12 months was reported as +0.23 in the Denosumab/Denosumab group and +0.11 in the Placebo/Denosumab group. Over the longer follow-up periods (6 to 36 months), the reported lumbar spine z-score changes varied across both groups, ranging from -0.23 to +0.57 depending on the group and time point. For the hip and upper leg area, reported z-score changes ranged from +0.22 to +0.75 across both groups and time points. Regarding fractures, the reported data shows that at each time point (12, 24, and 36 months), between 2 and 3 participants in each group had at least one confirmed bone fracture, and some participants in both groups also showed signs of existing vertebral (spine) fractures healing over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04729621 · results posted 18 April 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04729621) enrolled 166 people in each of two groups during the main treatment period — one group received a medicine called TVB-009 and the other received Prolia (denosumab), a medicine already approved for bone loss. The trial ran in two stages: a main treatment period up to 52 weeks, followed by a transition period up to week 78. The main thing being measured was the change in bone density in the lower spine (lumbar spine) after 52 weeks, assessed using a specialised X-ray scan called a DXA scan. The reported data shows that, at week 52, lumbar spine bone density had changed by an average of +4.76% from the starting point in the TVB-009 group, and +4.54% in the Prolia group. Earlier, at week 26, the reported change in lumbar spine bone density was +3.70% for TVB-009 and +3.62% for Prolia. The reported data also shows changes at the hip area at week 26: around +1.87–1.89% for TVB-009 and +2.01–2.02% for Prolia, depending on exactly which part of the hip was measured. The trial also measured a blood marker linked to bone breakdown (called sCTX-1); the reported figures showed this marker decreased by around 56–58% in the TVB-009 group and around 65–69% in the Prolia group at the time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01144468 · results posted 27 March 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT01144468) involved 351 postmenopausal women, with 176 assigned to take a daily 25 mg dose of exemestane and 175 assigned to take a placebo (a dummy pill with no active ingredient). The trial measured changes in bone density — specifically, the density of bone tissue in a particular part of the body — over a 24-month period. Bone density was measured using a specialised scanning technique called HR-pQCT, which produces detailed images of bone structure. By the end of the study, 124 participants in the exemestane group and 118 in the placebo group had completed the trial. The reported data shows that, on average, bone density changed in both groups over the 24 months. In the exemestane group, total volumetric bone mineral density decreased by an average of 6.1% from where it started at the beginning of the trial. In the placebo group, the average decrease was 1.8%. These are the average figures across each group — individual results would have varied from person to person. No other outcome measures were included in the structured results data submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02589600 · results posted 16 August 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT02589600) enrolled 310 people in total — 154 in the active medication group and 156 in the placebo group (a placebo is a dummy treatment with no active ingredient, used for comparison). The trial was measuring the rate of certain bone fractures — specifically non-traumatic fractures of the spine and other bones identified through imaging such as X-ray, CT, or MRI — expressed as the number of fractures per person per year. Fractures caused by serious accidents, cancer, or involving the toes, fingers, or face were not counted. Around 101–102 participants in each group completed the study, with 53–54 in each group not completing it. The reported data shows that the active medication group had a fracture rate of approximately 1.06 fractures per person-year, while the placebo group had a rate of approximately 1.02 fractures per person-year. In plain terms, "fractures per person-year" is a way of accounting for the fact that participants were followed for different lengths of time — it estimates how many fractures would occur for every person observed over one full year. The reported numbers for the two groups were very close to each other. No secondary outcome measures were included in the structured data submitted to ClinicalTrials.gov, so those results are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04026256 · results posted 2 August 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04026256) enrolled 34 participants in total, divided into three groups: 13 received teriparatide only, 9 received denosumab only, and 12 received a combination of both denosumab and teriparatide. Not everyone finished the study — 10, 8, and 9 participants completed it in each group respectively. The trial was measuring a specific process in bone tissue called the "cancellous bone formation rate," which is essentially a way of quantifying how much new bone was being built inside a particular type of bone tissue (the spongy inner layer of bone) at the 3-month mark. This was measured using small bone samples taken from the hip bone. The reported data shows the cancellous bone formation rate — expressed in units that reflect the volume of new bone formed per unit of surface area per day — differed across the three groups at 3 months. The teriparatide-only group had a reported rate of 0.13, the denosumab-only group had a reported rate of 0.01, and the combination group had a reported rate of 0.06. No secondary outcome measure data was included in the submitted results. It is important to note that these are measurements of a biological process in bone tissue samples, and the trial results do not include information on how participants felt or on broader health outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02186600 · results posted 27 June 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 276 women across three groups: a control group (93 people), a risedronate (a bone medication) group (91 people), and an exercise group (92 people). The trial was measuring changes in bone-related outcomes over time, including a measure called the Bone Strength Index (BSI) — a way of estimating how strong the lower leg bone is — as well as bone mineral density (a standard measure of how dense bones are) at the spine, and a blood marker related to how quickly old bone is being broken down by the body. The reported data shows that, for the primary measure — the Bone Strength Index of the lower leg — the starting values were approximately 2,099 for the control group, 1,993 for the risedronate group, and 2,001 for the exercise group. By the end of the study, those figures were approximately 2,107, 2,014, and 2,009 respectively. For the spine bone density measure, starting values were around 0.889, 0.892, and 0.886 grams per square centimetre across the three groups, ending at approximately 0.885, 0.911, and 0.885. For the blood marker of bone breakdown, starting values were roughly 14.0, 14.3, and 15.0 units across the three groups, with end-of-study values of approximately 12.4, 11.4, and 13.9 units. The reported data shows the recorded numbers across all three groups at each time point, but no further detail about statistical comparisons between groups was included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04064411 · results posted 15 February 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 511 people in total — 255 in one group and 256 in the other. It compared two different ways of delivering a medicine called abaloparatide: one group received it as a standard injection under the skin (called "Abaloparatide-SC"), while the other received it via a skin patch-like delivery system (called "Abaloparatide-sMTS"). The trial's main goal was to measure changes in bone density in the lower spine after 12 months, with additional measurements taken at the hip and femoral neck (the top of the thigh bone). Around 191–201 participants in each group completed the full study period. The reported data shows that, at 12 months, bone density in the lower spine increased by approximately 10.9% in the injection group and approximately 7.1% in the patch delivery group, compared to where each participant started. For the hip overall, the reported changes were approximately 3.7% and 2.0% respectively. For the femoral neck specifically, the reported figures were approximately 3.4% for the injection group and approximately 1.9% for the patch delivery group. These are the percentage changes from each participant's own starting (baseline) measurement, as assessed by specialised bone density scans. It is worth noting that the reported data describes what was measured and the numbers observed — it does not, on its own, tell us what those differences mean for people's health in a broader sense. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03812380 · results posted 17 August 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03812380) enrolled 44 people in total — 22 in a group receiving a supplement called EffCaMgCit (a combination of calcium, magnesium, and citrate) and 22 receiving a placebo (an inactive substitute). The trial was measuring changes over two years in several things related to bone and kidney health, including bone density scores (T-Score and Z-Score), how the body handles magnesium and creatinine (waste products used to assess kidney function), and a hormone called parathyroid hormone (PTH) that helps regulate calcium and bone. It is worth noting that the completion data shows very few participants formally completed the study — zero in the EffCaMgCit group and only one in the placebo group — which the reported data does not explain further. The reported data shows the following changes from the start of the trial to two years. For bone density, the T-Score figures reported were −0.4, −1.0, −0.7, and −0.3, and the Z-Score figures were −0.1, −0.8, −0.7, and −0.1; however, the data as submitted does not clearly separate which of these numbers belong to the EffCaMgCit group versus the placebo group, so a direct group-by-group comparison cannot be made from the available information. For the other primary measures, the reported changes were: a −1.0 percentage point change in how much magnesium the kidneys were excreting; a −0.044 mmol/L change in free magnesium measured in calf muscle; and a change of +13 ml/min in creatinine clearance (a rough measure of how well the kidneys filter waste). Again, the data does not specify which group these figures come from. For the secondary outcome, the reported change in parathyroid hormone (PTH) levels was +75 pg/ml, though group-level detail was also not reported separately. It is important to note that for several of the outcome measures, only a single combined figure was submitted rather than separate results for each group, meaning a full side-by-side comparison of the supplement versus placebo cannot be drawn from this data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03710889 · results posted 15 October 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03710889) enrolled 23 participants, all of whom received at least one dose of the study drug, abaloparatide. Twenty participants completed the study, and three did not. The trial was primarily looking at changes in a bone tissue measurement called mineralising surface/bone surface (MS/BS) — essentially, the proportion of bone surface that is actively forming new bone — taken from a small bone sample (biopsy) at the start of the study and again after three months. Nineteen participants provided bone biopsy samples suitable for this analysis. The reported data shows that, for the primary measurement (MS/BS in a specific layer of bone called the cancellous envelope), the figures recorded were 5.74% at the start of the study and 18.66% at three months. For a related bone formation measure (how much new bone volume is being built per unit of bone surface per year), the reported values were 0.011 at the start and 0.034 at three months. The trial also measured two markers found in the blood that are associated with bone metabolism. For one marker (s-P1NP, linked to bone building), the reported values were 54.990 ng/mL at the start, 119.155 ng/mL at one month, and 141.130 ng/mL at three months. For the other marker (s-CTX, linked to bone breakdown), the reported values were 0.460 ng/mL at the start, 0.052 ng/mL at one month, and 0.311 ng/mL at three months. It is worth noting that the data as submitted does not include some details that would normally help with interpretation, such as measures of spread or variability around these figures, so the numbers above represent the values as reported without further context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02371252 · results posted 29 September 2021

  According to the results reported on ClinicalTrials.gov, this trial involved 140 people in total — 70 in each group. One group took the original brand of alendronate (Fosamax) and the other took a generic version (Bonmax). All 140 participants completed the study, with no drop-outs recorded. The trial was measuring changes in bone mineral density (a measure of how dense or strong bones are) at two locations — the lower spine and the hip — over one year, as well as changes in certain substances in the blood that reflect bone activity. The reported data shows that, after one year, bone mineral density at the lower spine increased by an average of 5.54% in the Fosamax group and 5.39% in the Bonmax group. For bone density at the hip, the reported figures were a 2.48% increase in the Fosamax group and a 2.52% increase in the Bonmax group. These are the percentage changes from each participant's own starting measurement. For the two blood-based measures — one reflecting how quickly bone is broken down (serum CTX) and one reflecting how quickly new bone is formed (serum PINP) — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04271605 · results posted 18 June 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT04271605) enrolled 5 participants who received a combined behaviour and medication-based intervention. The trial ran from February 2020 to December 2020, when it was terminated early. Notably, none of the 5 participants completed the study — all 5 are recorded as having not completed it. The trial was measuring four things over that period: deaths, new heart-related events (such as heart attacks or strokes), new fragility fractures (broken bones caused by relatively minor impacts), and fall events. The reported data shows that across all four of these outcomes, the recorded number of participants experiencing each event was zero. That means zero deaths, zero new heart or stroke events, zero new fractures, and zero falls were recorded among the participants during the study period. It is important to note that because none of the 5 participants completed the study and the trial was terminated early, the reported data is very limited. Only 5 people were involved, which is a very small number, and the reasons for the early termination and non-completion were not reported in the data provided to ClinicalTrials.gov — so the context behind these numbers is unclear. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03051620 · results posted 18 March 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 142 participants in total, with 124 completing the study and 18 not completing it. The trial was looking at what happens to bone density in people who stop taking alendronate (a medication commonly used to strengthen bones), and whether a blood marker called CTX — which reflects how quickly bone is breaking down — could predict who would go on to lose a meaningful amount of bone density in the hip over the following year. The reported data shows that the primary question the trial was trying to answer involved plotting results on what researchers call a "receiver operating characteristic curve" — a way of measuring how well a test can predict an outcome, where a score of 50% would be no better than chance and 100% would be perfect. For the CTX marker measured three months after stopping alendronate, the reported figure was 49%, and at six months it was 64%. A separate figure of 1.14 (described as a percentage change) was also reported for this outcome, though the data does not make entirely clear what this specific number refers to in plain terms. For the secondary outcomes, the reported data shows that 85 out of the 142 participants had a CTX level that rose by more than 30% (the threshold considered a meaningful change). In terms of bone density loss beyond a clinically meaningful threshold, 21 participants lost bone at the lumbar spine and 26 lost bone at the total hip. Average bone density changes at the hip were reported as approximately −1.14% at one year and −2.65% at two years, though the data as submitted does not always make fully clear which specific time points each figure corresponds to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00058188 · results posted 19 November 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT00058188) involved two groups of participants: one group received zoledronate along with calcium and cholecalciferol (a form of vitamin D), while the other group received calcium and cholecalciferol alone. The trial was designed to look at changes in bone density over 13 months, as well as other bone-related outcomes such as bone fractures, signs of cancer spreading to the bones, and chemical markers in the blood that reflect how the body is building or breaking down bone. Unfortunately, the participant numbers submitted to ClinicalTrials.gov show zero for both groups across all milestones — meaning the number of people who started, completed, or left the study early was not properly reported in the structured data. The reported data shows no numerical results for any of the outcome measures — neither the primary measure (bone density change as assessed by a specialised scanning technique called dual-energy X-ray absorptiometry, which uses low-dose X-rays to measure bone strength) nor any of the secondary measures (including bone density on plain X-rays, bone marker levels in the blood, skeletal events such as fractures or spinal cord compression, or new or worsening cancer spread to bones). In each case, the measurements field in the submitted data is empty, meaning no figures were reported. Because no participant numbers or outcome results were included in the structured data submitted to ClinicalTrials.gov, it is not possible to describe what the trial found in any meaningful numerical way — any attempt to do so would involve guessing, which this summary does not do. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03432533 · results posted 10 April 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 283 people in total — 141 in one group and 142 in the other. Both groups received the same monthly injection of a medicine called romosozumab (210 mg), but through two different delivery devices: a pre-filled syringe (PFS) in one group, and an autoinjector pen (AI/Pen) in the other. The trial was measuring whether the two devices produced similar changes in bone density (a measure of how solid and strong bones are) at the spine and hip over six months. The reported data shows that, for the main measure — change in spine bone density after six months — the pre-filled syringe group showed an average increase of 9.2%, while the autoinjector pen group showed an average increase of 9.0%. For the secondary measures, total hip bone density rose by an average of 3.7% (syringe) and 3.6% (pen), and femoral neck bone density (the top of the thigh bone where it meets the hip) rose by 3.4% (syringe) and 3.6% (pen). The trial also tracked unwanted medical events: 94 people in the syringe group and 96 in the pen group experienced at least one adverse event during the study. Serious adverse events were reported in 7 people (syringe) and 4 people (pen), and device-related adverse events were reported in 7 people (syringe) and 15 people (pen). No deaths were reported in either group. The reported data also shows that 21 people (syringe) and 22 people (pen) developed antibodies — proteins the body can produce in response to a medicine — during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00745121 · results posted 26 November 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people in total — 20 in the osteoporosis/osteopenia group (people with reduced bone density) and 28 in the control group (people without that condition). The trial was measuring changes in the bone level around dental implants over a five-year period. However, not everyone finished the study: 9 people in the osteoporosis/osteopenia group and 2 in the control group did not complete it, meaning the final results are based on 11 and 26 participants respectively. The reported data shows that the primary outcome being tracked was "marginal bone level alteration" — this refers to how much the bone immediately surrounding a dental implant had changed in height (measured in millimetres from a fixed reference point on the implant) between the time the permanent restoration was fitted and the five-year follow-up. According to the results reported on ClinicalTrials.gov, the osteoporosis/osteopenia group showed an average change of −0.15 mm, while the control group showed an average change of −0.06 mm. A negative number indicates a small reduction in bone height around the implant over the five years. No secondary outcome measure data was included in the reported results. It is worth noting that the osteoporosis/osteopenia group had a notably higher drop-out rate than the control group, which may limit how much can be drawn from the numbers alone — though what those numbers mean clinically is a matter for a qualified health professional to interpret. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01921517 · results posted 15 November 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 80 participants in total — 42 in the active treatment group, who received a form of low-level mechanical stimulation (gentle vibration-like stimulation applied to the body), and 38 in the sham group, who received a dummy version of the same device that did not deliver the actual stimulation. The trial was measuring changes in bone quality at the lower leg (the distal tibia), using MRI scans to calculate the ratio of bone tissue to the total volume of the area — a higher ratio suggests denser, healthier-structured bone, while a lower ratio suggests weaker, more osteoporotic bone. Not everyone completed the trial: 27 participants in the active group and 29 in the sham group finished. The reported data shows that, over the course of the study, the active stimulation group had an average change in that bone quality ratio of +1.121 percentage points — meaning the ratio nudged slightly upward on average. In the sham (dummy device) group, the average change was −2.141 percentage points, meaning the ratio nudged slightly downward on average. The trial only reported this one primary outcome measure; no secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02791516 · results posted 5 July 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 67 participants in total — 33 receiving a placebo and 34 receiving a medicine called romosozumab (210 mg). The trial ran over six months and was primarily measuring changes in bone mineral density (BMD) — a measure of how dense or strong bones are — at the lower spine (lumbar spine). It also looked at BMD changes at the total hip and the femoral neck (the upper part of the thigh bone where it meets the hip). The reported data shows that, at the lumbar spine, participants in the placebo group had an average change of −0.1% in bone mineral density from the start of the trial to six months, while those in the romosozumab group had an average change of +9.5%. For the total hip, the reported data shows an average change of +0.3% in the placebo group and +2.9% in the romosozumab group. At the femoral neck, the reported figures were +0.8% for the placebo group and +3.0% for the romosozumab group. These are the percentage changes in bone density measurements as recorded and reported — not conclusions about whether the treatment should be used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01992159 · results posted 25 March 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 252 people in total — 63 in each of four groups. Three groups received different monthly doses of a medicine called romosozumab (70 mg, 140 mg, or 210 mg), while the fourth group received a placebo (a dummy injection with no active medicine). The trial ran for 12 months and was mainly measuring changes in bone mineral density — a way of measuring how dense or strong bones are — at the lower spine (lumbar spine), using a type of scan called a DXA scan. Most participants completed the study, with between 55 and 63 people finishing in each group. The reported data shows that, at the 12-month mark, bone mineral density at the lower spine changed by an average of 0.9% in the placebo group, 8.4% in the 70 mg romosozumab group, 13.3% in the 140 mg group, and 16.9% in the 210 mg group. For the secondary measurements — looking at bone density at the hip and the femoral neck (the top part of the thigh bone) — the reported data shows smaller percentage changes across all groups. For example, at 12 months, total hip bone density changed by 0.6% in the placebo group, rising to 4.7% in the 210 mg romosozumab group. At the femoral neck, the reported change was 0.3% for placebo and 3.8% for the 210 mg group at 12 months. Similar patterns were seen at the 6-month timepoints across all measurement sites. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01588509 · results posted 4 March 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 30 in each group — who received either a 140 mg or 210 mg dose of a medicine called romosozumab. The main thing the trial was measuring was how much a type of bone density (the amount of mineral in the bones) changed at the lower spine after treatment. Bone density was measured using a type of scan called a DXA scan, which is similar to an X-ray. Almost all participants completed the trial — 29 out of 30 in the lower-dose group and all 30 in the higher-dose group. The reported data shows that, at the lower spine, bone density changed by about +2.13% from where it started (called "baseline") in the 140 mg group, and about +2.08% in the 210 mg group. For secondary measurements — things the trial also tracked but were not the main focus — bone density at the femoral neck (the top of the thigh bone near the hip) changed by roughly +2.06% and +1.92% respectively, and at the total hip by about +1.38% and +1.40%. The trial also measured two blood markers related to bone activity: one marker that reflects bone building (P1NP) went up by roughly 127% and 205% in the respective groups at one measured timepoint, while a marker related to bone breakdown (sCTX) showed a range of changes across different timepoints, including both decreases and increases across the study period. The reported data also shows that, out of 30 participants in the 140 mg group, 14 experienced any kind of unexpected medical event (called an adverse event) during the trial, compared with 15 out of 30 in the 210 mg group. No serious adverse events — defined as those that were life-threatening, required hospitalisation, or caused lasting harm — were reported in either group. Three participants in the 140 mg group and four in the 210 mg group experienced adverse events that the investigators considered possibly related to the study medicine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01698463 · results posted 18 February 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 11 participants, all of whom completed the study with no drop-outs. The trial was looking at whether a program that identified patients at risk and provided them with an exercise prescription could change their physical activity levels over a six-week period. Researchers measured activity in two ways: using a small device worn on the hip (called an accelerometer) that tracked how many minutes per day participants spent moving, and a daily logbook where participants recorded how much of their prescribed exercise they actually completed. The reported data shows that, on average, participants recorded 21.6 minutes per day of physical activity as measured by the hip-worn device. In terms of the logbook self-reporting, participants completed on average 65.7% of their prescribed exercises over the six-week period. The trial also measured several psychological factors using questionnaire scores. For "action planning" (having a plan for when, where and how to exercise, scored out of 25), the reported average score was 21.00. For "coping planning" (having strategies to get around barriers like bad weather or lack of time, scored out of 20), the average was 14.55. For "coping self-efficacy" (confidence in one's ability to overcome those barriers, scored out of 45), the average was 34.45. For "intentions" (how motivated participants felt to do the recommended exercises, scored out of 15), the average was 12.0. It is worth noting that the data as reported does not separately show the starting (baseline) scores alongside the follow-up scores, so the change from beginning to end cannot be calculated from the figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01512446 · results posted 17 January 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01512446) involved 436 people in total — 221 who received a placebo (a dummy treatment) and 215 who received a medicine called alendronate, which is used in relation to bone health. The trial was measuring the number of new bone fractures linked to osteoporosis (a condition that weakens bones), as well as deaths and a combined count of fractures or deaths. The reported data shows that when it came to the primary (main) outcome — new osteoporotic fractures — both groups recorded the same number: 5 fractures each. For the secondary (additional) outcomes, the reported data shows that 2 deaths occurred in the placebo group and 0 in the alendronate group. When fractures and deaths were counted together, the placebo group had 7 participants affected and the alendronate group had 5. It is worth noting that the data shows zero participants were recorded as having "completed" the study, and all participants were listed under "not completed"; the reasons for this were not reported in the structured data provided. It is also important to note that the safety analysis — which looked at a slightly smaller group of people who actually received the treatments — included 197 people in the placebo group and 188 in the alendronate group, which is fewer than the number who started the trial. The reasons for this difference were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01631214 · results posted 12 December 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01631214) involved just over 4,000 postmenopausal women with osteoporosis. Participants were split into two groups of roughly 2,047 each: one group received the medication romosozumab for 12 months followed by alendronate (romosozumab/alendronate), and the other received alendronate throughout the entire period (alendronate/alendronate). The trial measured how often fractures occurred in each group over approximately two years, looking at fractures in the spine as well as elsewhere in the body. The reported data shows the following fracture rates by the end of the study period. For new spinal (vertebral) fractures over 24 months, 8.0% of participants in the alendronate-only group experienced one, compared with 4.1% in the romosozumab/alendronate group. For "clinical fractures" — meaning fractures that caused noticeable signs or symptoms in bones outside the neck and back — the reported figures were 13.0% versus 9.7%. For any fracture combined, the figures were 19.1% versus 13.0%. Looking at fractures outside the spine specifically, 10.6% of the alendronate-only group experienced one, compared with 8.7% in the romosozumab/alendronate group. For major non-spinal fractures (such as hip, forearm, ribs, and shoulder), the reported rates were 9.6% versus 7.1%. For new or worsening spinal fractures over 24 months, the figures were 9.2% versus 4.8%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02016716 · results posted 8 November 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 294 participants across three groups: 53 received a placebo (inactive treatment), 118 received romosozumab at a concentration of 70 mg/mL, and 123 received romosozumab at 90 mg/mL. The trial was measuring changes in bone mineral density (BMD) — a measure of how dense or strong bones are — at several sites in the body, including the lower spine, hip, and femoral neck (the top part of the thigh bone where it meets the hip). It also tracked two chemical markers found in the blood that reflect bone-building and bone-breakdown activity. Most participants completed the study: 47 in the placebo group, 110 in the 70 mg/mL group, and 117 in the 90 mg/mL group. The reported data shows that for the main outcome — change in lower spine bone density — the placebo group had an average increase of 0.8%, while the romosozumab 70 mg/mL group showed a reported increase of 9.6% and the 90 mg/mL group showed 9.2%. For total hip bone density, the placebo group showed virtually no change (0.0%), compared with reported increases of 3.9% and 3.4% in the two romosozumab groups respectively. At the femoral neck, the placebo group showed a small average decrease of 0.5%, while the romosozumab groups showed reported increases of 3.1% and 2.6%. The reported data also shows changes in the two blood markers of bone activity across multiple time points during the study, with the romosozumab groups showing larger fluctuations in both markers compared with the placebo group, though the specific time points for each set of figures were not labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01796301 · results posted 8 November 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 218 people in each of two groups — one group received a medicine called teriparatide and the other received a medicine called romosozumab. In total, 436 people started the study. Of those, 214 in the teriparatide group and 218 in the romosozumab group actually received their treatment, and around 200 people in each group completed the full 12 months. The trial was primarily measuring changes in bone mineral density (a measure of how dense or strong bones are) at the hip, using a type of scan called a DXA scan. The reported data shows that, for the primary outcome — the average change in total hip bone density across months 6 and 12 — the teriparatide group showed a change of **−0.6%** (a small decrease from their starting level), while the romosozumab group showed a change of **+2.6%** (a small increase from their starting level). Looking at individual time points, the reported data shows the teriparatide group's hip bone density was −0.8% at month 6 and −0.5% at month 12, compared with +2.3% and +2.9% for the romosozumab group at those same points. A second type of scan (called a QCT scan, which measures the density of the hard outer shell of the bone) also reported numbers: at the hip, the teriparatide group showed changes of −2.7% at month 6 and −3.6% at month 12, while the romosozumab group showed +0.7% and +1.1% at those time points. One further secondary measure — overall hip bone density by QCT at month 6 — showed −0.8% for teriparatide and +2.3% for romosozumab. Results for that QCT measure at month 12 were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01575834 · results posted 8 November 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01575834) enrolled just over 7,100 postmenopausal women in total — roughly 3,591 in one group and 3,589 in the other. For the first 12 months, one group received a placebo injection while the other received romosozumab; from months 12 to 24, both groups then switched to receiving denosumab (another bone medicine). The trial was measuring how many participants experienced new broken bones — particularly fractures in the spine (vertebral fractures), fractures elsewhere in the body (nonvertebral fractures), and fractures that caused noticeable symptoms (clinical fractures) — at both the 12-month and 24-month marks. The reported data shows the following results for new spinal fractures: at 12 months, 1.8% of participants in the placebo group had a new spinal fracture compared with 0.5% in the romosozumab group; by 24 months (after both groups had moved on to denosumab), those figures were 2.5% in the placebo/denosumab group and 0.6% in the romosozumab/denosumab group. For fractures that caused symptoms (clinical fractures), the reported data shows 2.5% versus 1.6% at 12 months, and 4.1% versus 2.8% at 24 months. For fractures outside the spine, the reported figures were 2.1% versus 1.6% at 12 months, and 3.6% versus 2.7% at 24 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00111241 · results posted 5 October 2018

  According to the results reported on ClinicalTrials.gov, this trial involved two groups of women: 45 women who had breast cancer and 70 healthy women used as a comparison group. The trial was measuring changes in the knee joint over two years — specifically the amount of cartilage (the cushioning tissue in the knee) and the size of the bone surface just beneath that cartilage. Of those who started, 30 of the 45 women in the breast cancer group and 62 of the 70 women in the healthy group completed the study. The reported data shows that, for knee cartilage volume (measured in cubic millimetres, a unit of volume), the breast cancer group returned a figure of 2,042 mm³ compared with 1,971 mm³ for the healthy comparison group. For the secondary measure — the area of the bone surface just below the knee cartilage (measured in square millimetres) — the reported figures were 2,020 mm² for the breast cancer group and 1,992 mm² for the healthy comparison group. These numbers represent the reported values at the end of the two-year measurement period, though the data submitted does not include further detail about how the change over time was calculated or whether the difference between the two groups was considered meaningful by the researchers. It is worth noting that 15 women in the breast cancer group did not complete the study, which the data does not explain further. No information about the reasons for non-completion was reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00697463 · results posted 26 July 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 22 women who had been diagnosed with idiopathic osteoporosis — a condition where bone density is lower than expected for a person's age, without a clear cause. Twenty-one of the 22 participants completed the study, and one did not finish. The trial was measuring changes in bone density in the lower spine (lumbar spine) over time, using a type of scan called a DXA scan, which is a standard way of measuring bone density. Scans were taken at the start of the study and then at 6, 12, 18, and 24 months. The reported data shows that, on average, lumbar spine bone density changed by 10.8% across the course of the study. This figure represents the average percentage change from where participants started (their baseline measurement) to the end of the study period. No other outcome measures were included in the results data submitted to ClinicalTrials.gov, so no further figures are available to report here. It is worth noting that this was a single group of participants with no comparison group reported in the submitted data, which means the 10.8% figure reflects change within that one group only. No information about what treatment or intervention was given was included in the structured results data provided, and no safety or side effect data was reported in the results submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01907269 · results posted 26 June 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,342 participants in each of two groups — one group received a video-based intervention about osteoporosis, and the other received usual care (no special intervention). The trial was measuring whether the video-based approach changed how many people started prescription osteoporosis medicines, had bone density scans, took calcium or vitamin D supplements, or spoke with a health care provider about osteoporosis. Participants filled out surveys at around 6 months and 18 months after the intervention. Not everyone completed the follow-up surveys — for example, at the 6-month point, 953 people in the video group and 1,053 in the usual care group completed the survey. The reported data shows that, for the main (primary) outcome — the number of people who said they started a prescription osteoporosis medicine — 157 participants in the video group and 153 in the usual care group reported doing so. For the secondary outcomes, the reported numbers of people who said they used calcium or vitamin D supplements, received a bone density scan, or spoke with a health care provider were broadly similar between the two groups across both time points. For example, bone density scans were reported by 290 (video group) versus 268 (usual care group) at one time point, and 530 versus 522 at another. The reported data shows that communication with a health care provider about osteoporosis was reported by 583 versus 573 participants at one time point, and 779 versus 806 at another. It is worth noting that the data as submitted does not always clearly label which measurements belong to which time point for the secondary outcomes, so those figures cannot be assigned with certainty to the 6-month or 18-month surveys. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00405392 · results posted 6 June 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 365 people across two groups. One group of 183 participants took a once-monthly tablet (ibandronate 150 mg) first and then switched to a once-weekly tablet (risedronate 35 mg), while the other group of 182 did the reverse. Both medicines are used for osteoporosis (a condition where bones become weaker). By the end of the trial, 153 people in the first group and 155 in the second group had completed the study. The trial was designed to measure which dosing schedule — monthly or weekly — participants said they preferred, as well as which they found more convenient. It also measured a blood marker (called CTx) that reflects how quickly bone tissue is breaking down. The reported data shows that when participants were asked about their overall preference, approximately 62% said they preferred the once-monthly ibandronate dosing, while around 21% said they preferred the once-weekly risedronate dosing. When asked specifically about convenience, the reported figures were higher: approximately 73% of participants chose the monthly schedule as more convenient, compared to about 14% who chose the weekly schedule (those who rated both equally convenient were not counted in this particular comparison). Regarding the blood marker for bone breakdown (CTx), the reported data shows an average reduction of around 57% from the starting level for both the monthly and weekly medicines — these figures were very similar to each other. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02001051 · results posted 8 May 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02001051) enrolled a very small number of participants — just four people in total. Two were placed in the "Operative Arm," meaning they received surgery to remove an adrenal gland (adrenalectomy) straight away, and two were placed in a "Delayed Operative Arm," meaning they waited before having surgery. The trial was looking at whether removing an adrenal gland led to improvements in related health conditions such as high blood pressure, diabetes, bone thinning, high cholesterol, and obesity. It also tracked unwanted medical events, possible adrenal cancer findings, results from a specific type of body scan, quality of life, and the best way to diagnose a hormone-related condition called subclinical hypercortisolism (where the body may be producing slightly too much of a stress hormone without obvious symptoms). The reported data shows that, for the main outcome of metabolic (body chemistry-related) improvement after surgery, one out of two participants in the Operative Arm showed normalisation or improvement, while zero out of two in the Delayed Operative Arm did. For the tracking of serious and non-serious unwanted medical events, zero participants in either group had any recorded. On the secondary outcomes, no participants in either group were found to have adrenal cancer after surgery. All participants — one in each group — were reported as having been diagnosed with the hormone condition using the specific body scan method. For quality of life questionnaires, two participants in the Operative Arm completed them compared to zero in the Delayed Operative Arm. The data for the outcome looking at which diagnostic test is best was not reported in the submitted results. It is important to note that only four people took part in this trial, which is an extremely small number, and the results as reported here cannot be used to draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01108068 · results posted 27 April 2018

  According to the results reported on ClinicalTrials.gov, this trial looked at a condition called OPPG (osteoporosis-pseudoglioma syndrome), a rare genetic disorder affecting bone strength. The trial investigated whether lithium might influence bone density in people with this condition. Ten participants with OPPG were enrolled in the lithium group, alongside 16 people without the condition who served as a comparison group. However, only 4 of the 10 lithium group participants completed the study — the remaining 6 did not finish, though the reasons are not detailed in the reported data. The comparison group of 16 all completed the study. The reported data shows that bone density was measured using a scanning technique called pQCT (a type of bone scan) of the lower leg, with results expressed as a "Z-score." A Z-score is simply a number showing how a person's result compares to the average for their age group — a score of zero means exactly average, negative numbers mean below average, and positive numbers mean above average. At the start of the study, the OPPG participants had an average Z-score of −2.19, meaning their bone density was well below the average for their age. The comparison group started at 0.04, close to average. At a later timepoint, the OPPG group's score was reported as −2.09 and the comparison group's as −0.30. For a secondary measurement, the reported data shows that only 2 of the OPPG participants who received lithium were able to have follow-up scans (3 others could not be scanned due to their size or having metal rods in their legs). Those 2 participants had Z-scores of −4.96 and −4.93 after 6 months on lithium. The researchers noted the number of participants was too small to draw any statistical conclusions from these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01928082 · results posted 7 March 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled only one participant in a single group receiving a transdermal (skin patch or gel) form of oestradiol, which is a type of oestrogen hormone. The trial was designed to measure how the treatment affected calcium levels in urine over 24 hours, as well as several markers in the blood related to bone health and vitamin D. However, the study was terminated early, and that one participant did not complete the trial. The reported data shows that because the study was terminated, no outcome measurements were collected or analysed for any of the planned measures. This includes the main outcome — changes in 24-hour urinary calcium — as well as the secondary measures, which were levels of vitamin D, two proteins linked to bone health (bone morphogenetic protein 2 and sclerostin), and blood levels of oestradiol and total calcium. None of these figures were reported, as no participants reached the point of being measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01120600 · results posted 6 December 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 147 participants in each group — one group took a 50 mg weekly dose of a drug called odanacatib, and the other took a placebo (a dummy pill with no active ingredient). In total, 294 people started the study. The trial ran for 24 months and was mainly measuring changes in bone mineral density (BMD) — a measure of how dense or strong bones are — particularly in the lower spine. Secondary measurements looked at BMD at the hip and thigh bone area, as well as certain chemical markers in blood and urine that are linked to how quickly the body breaks down bone tissue. The reported data shows that, for the main outcome, the odanacatib group had an average increase in lower spine BMD of about 6.86% from their starting point, while the placebo group had an average increase of about 1.27%. For the hip measurements, the odanacatib group showed increases ranging from roughly 1.69% to 2.77% depending on the specific part of the hip measured, while the placebo group's figures ranged from 0% to 0.66%. Regarding the bone breakdown markers measured in blood and urine, the reported data shows the odanacatib group had decreases in these markers (around –20% in blood and –61% in urine), whereas the placebo group's markers went up (around +57% in blood and +7% in urine). These are percentage changes from each participant's own starting level, not absolute measurements. It is worth noting that 128 out of 146 treated participants completed the study in the odanacatib group, compared with 115 out of 146 in the placebo group, meaning some participants did not finish the trial in both groups. No conclusions about why participants did not complete the study can be drawn from the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00471237 · results posted 5 September 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 564 participants across seven groups. Six groups received different treatments — a placebo (inactive treatment), one of four daily doses of an experimental tablet called ronacaleret (100 mg, 200 mg, 300 mg, or 400 mg), or a weekly capsule of alendronate (an existing bone medicine) — while a smaller seventh group of 41 people received daily injections of teriparatide (another existing bone medicine). The trial was measuring changes in bone density in the lower spine over 12 months, as well as tracking a number of safety-related outcomes such as abnormally high calcium levels in the blood, unusual blood test results, changes in blood pressure and heart rate, and heart tracing (ECG) findings. The reported data shows that after 12 months, the percentage change in lower spine bone density from the starting point was: placebo +0.03%, ronacaleret 100 mg +0.32%, ronacaleret 200 mg +1.39%, ronacaleret 300 mg +1.61%, ronacaleret 400 mg +1.62%, and alendronate +4.54%. Bone density change was not reported for the teriparatide group in this outcome. Regarding high blood calcium (hypercalcaemia), the reported number of participants who recorded levels above the pre-set threshold were: 0 in the placebo group, 1 in the ronacaleret 100 mg group, 1 in the 200 mg group, 4 in the 300 mg group, 11 in the 400 mg group, 0 in the alendronate group, and 1 in the teriparatide group. Notably, no participants in any group were reported to have withdrawn from the study specifically because of high calcium levels. The reported data also shows that the number of participants with notable blood or urine test results at any point during the study ranged from 14 to 28 across the ronacaleret, placebo, and alendronate groups, with 6 reported in the teriparatide group. For unusual blood pressure or heart rate readings, numbers ranged from 5 to 11 across groups. ECG findings reported as an unwanted event were recorded for between 0 and 5 participants per group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01153425 · results posted 4 August 2017

  According to the results reported on ClinicalTrials.gov, this trial compared two medications — Teriparatide (brand name Forteo) and Zoledronic Acid (brand name Reclast) — in people with osteoporosis or low bone density. A total of 33 people were enrolled: 16 in the Teriparatide group and 17 in the Zoledronic Acid group. Of those, 13 and 14 participants respectively finished the study, with 3 people in each group not completing it. The trial was measuring changes in the internal structure of bone using specialised imaging, looking at two specific features of bone architecture. The reported data shows that the main thing being measured was a ratio describing the shape of the tiny structures inside bone (called the trabecular surface-to-curve ratio — essentially a way of assessing how the fine scaffolding inside bone is organised). The Teriparatide group showed a reported change of 9.1%, while the Zoledronic Acid group showed a reported change of 7.1%. A secondary measure looked at the percentage of a bone sample that is actually made up of bone tissue (called bone volume fraction). The reported data shows a change of 1.0% in the Teriparatide group and 0.6% in the Zoledronic Acid group. No other outcome figures were reported in the submitted data. It is worth noting that this was a small study with fewer than 20 people in each group, which limits how broadly these numbers can be interpreted. The reported data shows differences in measurements between the two groups, but what those differences mean in a broader context was not described in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00925600 · results posted 30 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 769 participants in total — 386 in the placebo group and 383 in the denosumab group. The trial was looking at whether denosumab (a medication) affected the development or worsening of clouding of the eye's lens (a condition related to cataracts) compared to a placebo (a dummy treatment). Eye lens cloudiness was measured using a standard grading system called LOCS III, which scores different types of lens clouding on a numbered scale. The trial ran for 12 months, and most participants — 354 on placebo and 355 on denosumab — completed the study. The reported data shows that for the main (primary) outcome — the percentage of participants whose lens clouding developed or worsened by month 12 using the standard threshold — the figures were nearly identical: 33.2% in the placebo group and 33.5% in the denosumab group. Additional pre-specified measurements were also reported. At the 6-month mark, 19.3% of the placebo group and 19.0% of the denosumab group showed lens clouding development or progression. Using a stricter definition of worsening, 10.7% (placebo) and 8.4% (denosumab) met that threshold by month 12. When only "confirmed" episodes of worsening were counted (meaning the change had to show up on two consecutive check-ups), 18.3% of the placebo group and 16.1% of the denosumab group were affected. The reported data also shows that small percentages of participants in both groups experienced a meaningful drop in their best-corrected vision (the sharpest vision achievable with glasses) over the course of the study, with figures ranging roughly from around 4% to 7% depending on the time point, across both groups. Changes in the lens prescription (measured in diopters, a unit for optical correction) needed to achieve best vision were also reported and appeared very small in both groups across all time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01507662 · results posted 11 April 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01507662) involved 7,749 people in total — 3,898 in one group and 3,851 in a control group. The study was looking at whether sending patients a letter with their bone density (BMD) scan results, along with a brochure, made a difference in whether their doctors prescribed treatment that matched established guidelines for osteoporosis (a condition where bones become weaker and more likely to break). The trial measured how many people in each group received care that matched those guidelines. The reported data shows that the main outcome measured was called "guideline concordant osteoporosis therapy." In plain terms, this means whether each person either received the recommended bone-strengthening treatment when their results suggested they needed it, or appropriately did *not* receive treatment when their results suggested they didn't need it. According to the results reported on ClinicalTrials.gov, 2,537 out of 3,898 people in the letter-and-brochure group met this guideline-concordant standard, compared with 2,477 out of 3,851 people in the control group. No other outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01871519 · results posted 7 February 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01871519) enrolled 350 people who all received a procedure called balloon kyphoplasty — a minimally invasive procedure used for spinal fractures. Of the 350 who started, 260 completed the study, while 90 did not finish. The trial was measuring changes in back pain, back function, and quality of life over time, with the main check-in point at three months after the procedure. The reported data shows that, on average, participants rated their back pain at 8.7 out of 10 (where 10 is the worst possible pain) before the procedure. At three months, the average pain score was reported as 2.7 — a reported change of minus 6.0 points on that scale. For back function, participants scored an average of 63.4 out of 100 on a disability scale (where higher means more disability) before the procedure, dropping to 27.1 at three months — a reported change of minus 35.3 points. Two quality-of-life scores were also measured: one (called the SF-36 physical component) went from an average of 24.2 to 36.6 (higher is better, so this was a reported increase of 12.4 points), and another (the EQ-5D, where 1.0 represents perfect health) went from 0.383 to 0.746, a reported change of plus 0.351. The reported data also shows pain and back function scores at additional follow-up points beyond three months. Back pain scores were reported as 3.4, 3.2, 2.5, 2.3, and 2.4 at later time points, while back function (disability) scores were reported as 32.5, 25.7, and 25.8 at later follow-up visits. The specific time points for each of these later measurements were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00887354 · results posted 9 January 2017

  According to the results reported on ClinicalTrials.gov, this trial compared two medications — teriparatide and risedronate — in people who had suffered a hip fracture. The trial looked at changes in bone density (how dense and strong the bones are, measured in grams per square centimetre), physical wellbeing, and hip pain over time. A total of 111 people were enrolled in the teriparatide group and 113 in the risedronate group at the start. After the first 26-week treatment phase, 60 and 65 people respectively continued into a longer open-label phase (where everyone knew which treatment they were receiving) running to 78 weeks. The reported data shows that the primary outcome — change in bone density at the lower spine — was measured at 78 weeks. The teriparatide group showed a reported average increase of 0.094 g/cm², while the risedronate group showed a reported average increase of 0.055 g/cm². For the hip area of the non-fractured leg, the reported changes in bone density were very small in both groups and close to zero across the different time points measured. On the physical wellbeing questionnaire (scored 0–100, where higher means better), both groups reported improvements over time, with scores rising by roughly 7 to 16 points in the teriparatide group and 5 to 14 points in the risedronate group at various time points. For hip pain measured on a 0–100 scale (where higher means more pain), the teriparatide group reported average scores of around 16, 9, 7, and 4 mm at successive time points, while the risedronate group reported scores of around 24, 19, 18, and 14 mm at the same time points. The data was not reported in a way that allows direct conclusions about why these differences occurred. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02014467 · results posted 31 October 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 484 people in total — 365 received denosumab 60 mg and 119 received a placebo (an inactive injection used for comparison). Of those, 340 and 112 respectively completed the study. The trial was measuring changes in bone mineral density (BMD) — essentially, how much mineral is packed into the bone tissue — at several sites in the body, including the lower spine, hip, and upper thigh bone. Scans were taken at 6 months and 12 months and compared to each participant's starting measurement. The reported data shows that the main outcome — the percentage change in lower spine BMD at 12 months — was +5.22% in the denosumab group and +0.79% in the placebo group from their starting levels. For the secondary outcomes at 6 months, the reported data shows lower spine BMD changed by +3.77% (denosumab) versus +0.57% (placebo); total hip BMD by +2.36% versus +0.11%; femoral neck (the top part of the thigh bone) BMD by +1.91% versus +0.32%; and the trochanter (another part of the upper thigh bone) by +2.76% versus −0.59%. At 12 months, total hip BMD changed by +3.03% (denosumab) versus −0.28% (placebo). These are the percentage-point changes in bone density measurements as recorded at each time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00545779 · results posted 28 October 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 677 participants, all of whom were taking a daily or weekly bisphosphonate (a type of bone-strengthening tablet) for osteoporosis. Of those, 633 completed the study, and 44 did not finish. The trial was designed to look at patient satisfaction and preferences around dosing schedules — specifically, whether switching from a daily or weekly tablet to a once-monthly tablet (ibandronate) might be something participants would prefer or feel more satisfied with. It was conducted in two parts: Part A used a short questionnaire to identify who might benefit from a monthly option, and Part B involved actually taking the monthly tablet for six months. The reported data shows that in Part A, 68.1% of participants answered "yes" to at least one question on the candidate identification questionnaire — meaning they either preferred a monthly schedule, had experienced stomach upset with their current tablet, or had missed doses. After completing six months on the monthly tablet in Part B, 67.5% of participants reported preferring the monthly option. When looking at changes in a satisfaction score (rated from 0 to 100, where higher means more satisfied), the reported data shows that between approximately 77% and 89% of participants had a higher satisfaction score at six months compared to when they started, depending on which sub-group they were in. For a secondary measure, 98.6% of participants took at least 80% of their six scheduled monthly doses during Part B. The reported data also shows that among those who improved on individual satisfaction questions, figures ranged from around 80% to 95% depending on the specific question asked, though some of these sub-group breakdowns were not fully labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00397462 · results posted 26 September 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 44 people in total, split across three groups: 16 in a "low use" group, 13 in a "high use" group, and 15 in a control group (meaning they did not receive the active intervention). All 44 participants completed the study with no dropouts. The trial was measuring changes in bone density — specifically how dense the bones were — at two sites in the body: the upper part of the thigh bone (proximal femur) and the upper part of the shin bone (proximal tibia). Bone density was measured using a type of low-dose X-ray scan called DXA. The reported data shows that, for bone density at the upper thigh bone, the control group had a very small decrease of 0.133%, the low use group had a decrease of 0.675%, and the high use group had an increase of 1.3%. These figures represent percentage changes in bone density over the course of the study. For the secondary measure — bone density at the upper shin bone — the reported data shows the control group had an increase of 1.14%, the low use group had a decrease of 2.111%, and the high use group had an increase of 1.65%. These are the percentage changes as submitted by the study sponsor, and no additional detail about the timeframe or statistical analysis was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01668589 · results posted 20 September 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,501 people across four European countries — 600 in Germany, 300 in Austria, 300 in Greece, and 301 in Belgium. All participants had already received at least one injection of a medicine called denosumab (used for bone conditions) before joining the study. The trial was not testing whether the medicine itself worked medically; instead, it was measuring how consistently participants kept to their scheduled injections over two years — that is, whether they stayed "on track" (called persistence and adherence) and how much of their time over the two years was actually covered by the medicine. The reported data shows that at the 12-month mark, between roughly 89% and 96% of participants across the four countries were still receiving their injections on schedule (persistence), and between about 85% and 90% were doing so within the stricter timing window used to define adherence. By 24 months, those figures were lower: persistence ranged from around 75% to 86%, and adherence from about 63% to 70%, depending on the country. A separate measure — the proportion of days over the study period that participants were covered by the medicine — was reported as between about 93% and 96% at 12 months, and between about 87% and 92% at 24 months. Among participants who did stop their injections early, the reported average time before stopping ranged from around 6 months to just over 12 months across the four countries. The reported data also shows that hip bone density measurements changed by between approximately 4% and 6.6% from the start of the study to 24 months, though what this means clinically was not assessed within this trial's reported outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00048061 · results posted 30 May 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,602 participants across four groups, each receiving a different dose or dosing pattern of a medication called ibandronate (2.5 mg daily, 50/50 mg alternating monthly, 100 mg monthly, or 150 mg monthly). The trial was measuring changes in bone mineral density (BMD) — essentially, how dense or strong bones are — in the lower spine and hip area over one and two years. Around 1,291 participants completed the full study period. The reported data shows that after 12 months, the average bone density in the lower spine increased across all four groups compared to where participants started, ranging from about 3.7% in the 2.5 mg group up to about 4.8% in the 150 mg group. After 24 months, the reported increases were larger, ranging from roughly 5.0% to 6.6% depending on the dose group. Hip bone density also showed reported increases across all groups at both time points, with the 150 mg group consistently showing the largest reported percentage change. The reported data also shows that between approximately 84% and 94% of participants in each group had spine bone density that stayed the same or went up compared to their starting measurement, at both the one- and two-year marks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00545051 · results posted 12 May 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 68 people in the ibandronate (a bone-related medication) group and 72 people in the placebo (dummy treatment) group — 140 participants in total. The trial ran for 12 months and was primarily measuring changes in bone mineral density (BMD — a measure of how dense or strong bones are) in the lower spine, using a type of scan called a DXA scan. Secondary measurements included hip bone density and levels of certain proteins in the blood that reflect how quickly bone is being broken down and rebuilt (known as bone turnover markers). The reported data shows that, for the primary outcome, the ibandronate group had an average increase in lumbar spine (lower back) bone density of 3.2% from the start of the trial to month 12, while the placebo group had an average change of -0.1% over the same period. For the secondary outcomes, at month 6 the ibandronate group showed a 2.6% average increase in lumbar spine bone density compared to 0.3% in the placebo group. For total hip bone density, the reported figures were a 0.7% increase (ibandronate) versus 0.0% (placebo) at month 6, and 1.2% (ibandronate) versus -0.7% (placebo) at month 12. The bone turnover markers showed percentage reductions of roughly 42–63% in the ibandronate group across the measurement points, compared to much smaller changes — and in some cases slight increases — in the placebo group. The reported data shows that no participants in either group were withdrawn due to a significant worsening in bone density at any site. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01690000 · results posted 6 May 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 81 people in total — 40 in the melatonin group and 41 in the placebo group (a placebo is a dummy treatment with no active ingredient). The trial was looking at whether melatonin had any effect on bone mineral density (BMD), which is a measure of how dense and strong bones are. By the end of the study, 37 people in the melatonin group and 35 in the placebo group had completed the trial, with a small number dropping out from each group. The reported data shows that bone mineral density was measured using DXA scans (a type of X-ray that measures bone density) at the start and end of the trial, with results expressed as a percentage change. The melatonin group showed an average change of −0.05%, meaning their bone density was almost unchanged on average. The placebo group showed an average change of −1.45%, meaning their bone density decreased by a slightly larger amount on average. These are the numbers as submitted; the trial did not report what, if any, statistical significance was assigned to this difference. For the secondary outcome — changes in calcium levels in the blood and urine (calcium homeostasis) — the reported data shows that no results were submitted to ClinicalTrials.gov for this measure, so those figures are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01426555 · results posted 10 March 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01426555) enrolled 70 people with spinal cord injury (SCI), split evenly into two groups of 35. One group took part in a rowing exercise programme using functional electrical stimulation (FES — a technique that uses small electrical pulses to activate muscles that can no longer move on their own), while the other group did the same rowing programme and also received an infusion of a medication called Zoledronic acid (ZA). The trial was designed to look at whether these approaches had any effect on bone density and bone structure in people with SCI. Of the 70 who started, 17 people in the rowing-only group and 20 people in the ZA infusion group were recorded as having completed the study. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for either the primary outcome measure (changes in bone mass, density, and structure) or the secondary outcome measure (whether a type of bone scan called DXA scanning is a reliable tool for tracking bone changes in people with SCI). In other words, while the trial recorded how many participants started and finished, the actual measurement data for both outcomes was not reported in the structured results on ClinicalTrials.gov. Because no outcome numbers were provided in the submitted data, it is not possible to describe what the trial found in terms of any changes to bone density or to confirm whether the DXA scanning method was validated. The reasons for the large number of participants who did not complete the study, and why outcome data was not reported, are also not explained in the available information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02598934 · results posted 9 March 2016

  According to the results reported on ClinicalTrials.gov, this trial involved 308 people in total — 154 in a "consult group" (who received some form of consultation) and 154 in a "non-consult group." All participants took ibandronate (a medication used in relation to bone health). The trial was measuring changes in several blood and urine markers linked to bone activity over six months, as well as how confident participants felt in the medication. By the end of the study, 135 people in the consult group and 132 in the non-consult group had completed it. The reported data shows that, looking at all 308 participants together, the main marker being tracked — a blood measure called CTX, which reflects bone activity — showed an average percentage change of around −55% from the start of the trial to the six-month mark. The reported data also shows changes across four other bone-activity markers measured in blood and urine: one called NTX (urine) showed an average change of around −46%; another called P1NP (blood) showed around −58%; osteocalcin (blood) showed around −42%; and BSAP (blood) showed around −35%. These figures represent the average percentage difference between participants' readings at the start and at six months — they do not on their own indicate whether those changes are beneficial, harmful, or meaningful for any individual. For the confidence-related measure, the reported data shows that in the consult group, between roughly 62% and 72% of participants reported being "confident" or "very confident" in the medication across different questions, depending on the specific question asked. In the non-consult group, those figures ranged from approximately 47% to 55%. No other breakdowns were provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00853723 · results posted 24 February 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 105 people in total — 35 in each of three groups. One group received a lower daily dose of a substance called PTHrP (400 micrograms), another received a higher dose of PTHrP (600 micrograms), and the third received a daily dose of PTH (20 micrograms), a related hormone used as a comparison. The trial was measuring how the body's bone-building and bone-breakdown activity changed over time, using two chemical markers found in the blood, as well as changes in bone density at several sites in the body. By the end of the study, 29, 28, and 33 participants had completed their respective groups. The reported data shows that for the main bone-building marker (called P1NP), levels rose across all three groups over the course of the trial. The reported percentage increases from the starting point at the final measurement point were approximately 46% for the lower PTHrP dose group, 84% for the higher PTHrP dose group, and 171% for the PTH group. For the main bone-breakdown marker (called CTX), the reported percentage changes at the final measurement point were approximately 33% for the lower PTHrP dose group, 26% for the higher PTHrP dose group, and 92% for the PTH group. For bone density, the reported data shows small percentage changes from baseline: at the lower spine, roughly +1.9%, +1.5%, and +2.2% for the three groups respectively; at the hip, roughly +0.7%, +0.7%, and +0.5%; at the femoral neck (top of the thigh bone), roughly +0.9%, +0.5%, and +0.6%; and at the forearm, roughly −0.5%, −1.0%, and −1.0%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00048074 · results posted 3 February 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,382 people across three groups. One group (465 people) took a daily ibandronate tablet (2.5 mg), a second group (448 people) received an injection of ibandronate (2 mg) into a vein every two months, and a third group (469 people) received a slightly higher-dose injection (3 mg) every three months. The trial was measuring changes in bone mineral density (BMD) — a scan-based measure of how dense or solid bones are — mainly in the lower spine, and also in the hip area. By the end of the study, 384, 361, and 372 participants in each group respectively had completed the trial. The reported data shows that, when looking at the primary outcome — the percentage change in lower spine bone density after 12 months — the daily tablet group showed an average increase of about 3.8%, the two-monthly injection group showed about 5.1%, and the three-monthly injection group showed about 4.8%. At 24 months, the reported figures were approximately 4.8%, 6.4%, and 6.3% respectively. Similar patterns were reported for hip bone density measurements at both 12 and 24 months, with all three groups showing increases from their starting point. The trial also measured a blood marker called CTX, which reflects how quickly the body is breaking down bone tissue. The reported data shows that all three groups had reductions in this marker of roughly 41–55% across the various time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01732770 · results posted 25 January 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 643 participants in total — 322 in one group and 321 in another. One group received zoledronic acid (5 mg, given once every 12 months by infusion), and the other received denosumab (60 mg, given every 6 months by injection). The trial was measuring changes in bone mineral density — a way of gauging bone strength — at the lower spine and hip after 12 months. Most participants completed the study: 312 in the zoledronic acid group and 313 in the denosumab group. The reported data shows that, at the 12-month mark, both groups had higher bone mineral density at the lumbar spine (lower back) compared to when they started. In the zoledronic acid group, the reported average increase at the lumbar spine was 1.1%, while in the denosumab group it was 3.2%. At the total hip, the reported data shows an average increase of 0.6% for the zoledronic acid group and 1.9% for the denosumab group. These same figures were reported for both the primary analysis and a secondary analysis that looked at the same measurements using a different statistical approach. It is worth noting that this trial was designed to compare the two treatments against each other, and the figures above are averages across each group — individual results within those groups would have varied. The reported data does not tell us anything about side effects or longer-term outcomes, as that information was not included in the structured results provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01290094 · results posted 13 August 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 41 participants, all of whom received a treatment called ibandronate. Thirty-five participants completed the study, while six did not finish. The trial was measuring changes in bone density — that is, how solid and dense the bones are — in two areas of the body: the lower spine (lumbar spine) and the hip. Bone density was measured at the start of the study and again at 12 months and 24 months. The trial also tracked something called a "T-score," which is a way of comparing a person's bone density to that of a healthy 30-year-old — the lower (more negative) the T-score, the lower the bone density relative to that reference point. The reported data shows that, on average, lumbar spine bone density increased by 5.67% after 12 months and by 5.27% after 24 months compared to where participants started. For the hip, the reported average increase was 2.68% at 12 months and 1.71% at 24 months. The reported data also shows changes in T-scores: the lumbar spine T-score changed by an average of 13.47% at 12 months and 12.48% at 24 months compared to the starting point, while the hip T-score changed by an average of 9.31% at 12 months and 5.98% at 24 months. These figures describe the changes measured across the group as a whole. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00221299 · results posted 25 June 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 49 people across four groups, all of whom were receiving some combination of a parathyroid hormone injection (called rhPTH or teriparatide) and/or a bone medication called risedronate, or a placebo (dummy treatment) version of one or both. The trial was designed to look at changes in bone mineral density (BMD) — a measure of how dense and strong bones are — particularly at the lumbar spine (lower back) and hip, with scans taken every six months. Most participants completed the study: 45 out of 49 finished, with four not completing for reasons not detailed in the reported data. The reported data shows that the primary outcome being tracked was the percentage change in lumbar spine BMD. Three of the four groups were included in this measurement. The group receiving parathyroid hormone with a risedronate placebo showed an average change of 0.85%, the group receiving both parathyroid hormone and risedronate showed an average change of 0.84%, and the group receiving a parathyroid hormone placebo with risedronate showed an average change of 0.91%. Results for the fourth group were not reported in the data submitted. No figures for hip BMD changes appear to have been reported in the submitted results data. It is worth noting that the trial itself described this as a small pilot study — meaning it was an early-stage study intended to explore patterns rather than draw firm conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00939874 · results posted 12 June 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 52 people, all of whom received a HIV medication called raltegravir. The trial was measuring changes in bone mineral density (a measure of how dense and strong bones are) in the lower spine and hips over time, as well as whether participants' HIV remained at very low levels in the blood. By the end of the study, 32 people had fully completed it, while 20 did not finish for various reasons. The reported data shows that bone mineral density in the lower spine increased by an average of 2.7% at week 48 and 3.0% at week 96. In the hips, the reported figures were an average increase of 2.3% at week 48 and 1.9% at week 96. These are percentage changes from where each participant started at the beginning of the trial. For the secondary outcome, the reported data shows that 90.6% of participants had HIV levels in the blood below 50 copies per millilitre — a threshold commonly used to indicate very low, hard-to-detect levels of the virus. It is worth noting that the trial involved only one group (everyone received raltegravir), so there was no comparison group reported in this data. Some outcome details, such as individual timepoint breakdowns for the hip measurements, were not fully separated in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01387672 · results posted 8 May 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 229 participants across six groups, each receiving a different form or dose of nitrate medication — an oral tablet (ISMO), a skin patch (Nitro-Dur), a skin ointment (Nitrol), two different doses of a dissolving tablet placed under the tongue (Nitrostat at 0.3 mg and 0.6 mg), or a placebo ointment. The trial was measuring changes in bone turnover markers — that is, substances in the blood that can indicate how quickly bone is being broken down or rebuilt. These markers included P1NP, Osteocalcin, and Bone-specific alkaline phosphatase (which relate to bone building) and CTX (which relates to bone breakdown). Between 202 and 229 participants completed their assigned treatment period, with the placebo group having the highest completion rate. The reported data shows the results as percentage change from the starting point (baseline) for two of the bone turnover markers across the six groups. For the first marker measured, the reported percentage changes ranged from approximately −6.1% (0.3 mg sublingual group) to +2.9% (0.6 mg sublingual group), with the other groups falling in between. For the second marker measured, changes ranged from approximately −4.5% (ointment group) to +4.2% (placebo group). The reported data does not clearly label which specific bone marker corresponds to each set of figures, so a direct marker-by-marker comparison cannot be made from the information provided. For the secondary outcome, headache severity was recorded during a run-in phase using a 0–10 scale (where 0 means no headache and 10 means a terrible headache). The reported data shows scores of 2.1, 3.1, 1.5, 0.36, and 0.6 across measurement time points for a single group during this phase; however, the data as submitted does not provide separate headache scores broken down by each of the six treatment groups for the main treatment period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00467285 · results posted 14 January 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 96 people with diabetes — 32 in Group 1 and 64 in Group 2. Of those, 28 and 60 respectively completed the study (4 people in each group did not finish). The trial was measuring whether taking a diabetes medication called pioglitazone was associated with differences in bone density (the amount of mineral in bones, which reflects bone strength) and bone turnover markers (substances in the blood that indicate how quickly bone is being broken down or rebuilt), compared to people with diabetes who were not taking pioglitazone. Measurements were taken at the start and again at six months. The reported data shows the following changes in bone density over six months. At the femoral neck (the top of the thigh bone near the hip), the pioglitazone group had a reported change of −3.2%, while the no-pioglitazone group had a change of +0.25%. At the total hip, the reported figures were −3.5% for the pioglitazone group and −0.2% for the no-pioglitazone group. At the spine, the reported changes were −0.1% for the pioglitazone group and +0.89% for the no-pioglitazone group. For the bone turnover markers, the reported data shows that osteocalcin (a protein linked to bone formation) changed by −20.49% in the pioglitazone group and −12.44% in the no-pioglitazone group. A separate bone breakdown marker called CTx showed a percentage change of +29% in the pioglitazone group and +19% in the no-pioglitazone group at six months. Note that some CTx data appeared to be recorded in two different formats and the data as submitted was not entirely consistent, so those particular figures should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00625391 · results posted 18 August 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 171 participants across four groups: a placebo group (44 people), a green tea polyphenols (GTP) group (47 people), a placebo plus Tai Chi group (42 people), and a GTP plus Tai Chi group (38 people). The trial was measuring two things in postmenopausal women: the balance between bone formation and bone breakdown (using biological markers detectable in the body), and a measure of "oxidative stress" — a type of cellular damage that can be tracked through a urine test. By the end of the study, the number of people who completed the trial was 37, 39, 37, and 37 across the four groups respectively. The reported data shows the following for the primary outcome — the ratio of a bone formation marker to a bone breakdown marker, expressed as a percentage change from the starting point (where 100% means no change): the placebo group recorded 106.1%, the GTP group 103.6%, the placebo plus Tai Chi group 112.3%, and the GTP plus Tai Chi group 113.0%. For the secondary outcome — the oxidative stress marker measured in urine — the reported data shows the placebo group recorded 73.5 units, the GTP group 33.5 units, the placebo plus Tai Chi group 29.7 units, and the GTP plus Tai Chi group 20.6 units. These are the numbers as submitted; no further detail about what these differences may or may not mean was included in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02042872 · results posted 28 July 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT02042872) involved 21 people in total — 8 in a group receiving zoledronic acid (a medication given by infusion) and 13 in a group receiving no treatment. The trial was measuring bone mineral density (BMD), which is a measure of how dense or strong bones are, at several sites in the body — the lower end of the thigh bone, the upper end of the shin bone, and the hip. Measurements were taken at the start of the trial and again at 12 months. It is worth noting that 5 participants in the no-treatment group did not complete the study, meaning only 8 people in that group were included in the final results. The reported data shows the following BMD figures (measured in grams per square centimetre, g/cm²) for the primary outcome at the knee area. At the lower thigh bone: the zoledronic acid group measured 1.102 at the start and 0.898 at 12 months; the no-treatment group measured 1.134 at the start and 1.038 at 12 months. At the upper shin bone: the zoledronic acid group measured 1.274 at the start and 1.022 at 12 months; the no-treatment group measured 1.341 at the start and 1.237 at 12 months. For the secondary outcome at the hip, the reported data shows the zoledronic acid group measured 1.125 at the start and 1.042 at 12 months, while the no-treatment group measured 1.020 at the start and 0.814 at 12 months. No further detail about the statistical comparison between groups was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01350934 · results posted 22 July 2014

  According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants comparing two different treatments for bone health: one group took a medicine called Fosamax Plus, and the other took a medicine called Calcitriol. In the first phase of the trial (the "base study"), 111 people started in the Fosamax Plus group and 108 in the Calcitriol group. Those who completed that first phase then moved into an extension study. Across both phases, the trial was measuring changes in bone mineral density (a scan-based measure of how dense or strong bones are) at the lower spine, as well as changes in two blood markers that reflect how quickly bone tissue is being broken down and rebuilt in the body. The reported data shows that, at the six-month mark, the Fosamax Plus group's lumbar spine bone density had increased by an average of 3.54% from their starting point, compared with 1.59% in the Calcitriol group. By twelve months, those figures were reported as 5.17% for Fosamax Plus and 2.26% for Calcitriol. For the two blood markers of bone turnover — known as s-P1NP and s-CTx — the reported data shows reductions in both groups at both time points. In the Fosamax Plus group, s-P1NP fell by around 59% at six months and 68% at twelve months, while in the Calcitriol group the reported reductions were around 17% at both time points. For s-CTx, the Fosamax Plus group showed reported reductions of around 79% at six months and 76% at twelve months, compared with around 27% and 24% respectively in the Calcitriol group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00050011 · results posted 28 January 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 602 people in total — 301 in each group. All participants were receiving treatment that put them into an early menopause (such as for breast cancer), and the trial was comparing two approaches to giving a bone-strengthening infusion called zoledronic acid: starting it straight away ("upfront") versus delaying the start. The main thing being measured was how much the bone density in the lower spine changed over 12 months. Bone density is a measure of how dense or solid bones are, and it was assessed using a specialised X-ray scan. The reported data shows that at 12 months, the upfront group's lower-spine bone density had increased by about 1.96% from where it started, while the delayed-start group's bone density had fallen by about 2.33%. When the same measure was tracked further out, the reported figures continued in the same direction — for example, at the longest follow-up point measured, the upfront group showed roughly a 6.2% increase from baseline while the delayed-start group showed roughly a 2.4% decrease. For hip bone density, similar patterns were reported across all time points. Blood markers related to bone activity (measured in a smaller subgroup of 231 participants) also moved in opposite directions between the two groups, though several of the later time-point figures were listed as "not available" in the submitted data. Regarding fractures, 18 participants in the upfront group and 21 in the delayed-start group were reported to have experienced a clinical fracture by 36 months. For the measure of time to disease recurrence, the median figure was not reported in the submitted data for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00089791 · results posted 10 January 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 3,906 people in the placebo group and 3,902 people in the denosumab (60 mg every 6 months) group — nearly 7,800 participants in total. The trial was measuring how many people in each group experienced certain types of bone fractures over the course of the study, specifically fractures of the spine (vertebral fractures), fractures at other sites in the body (non-vertebral fractures), and hip fractures in particular. The reported data shows that for the main outcome — new spinal fractures — 264 participants in the placebo group experienced one, compared to 86 participants in the denosumab group. For non-vertebral fractures (breaks at sites other than the spine, skull, hands, and feet), the reported data shows 293 participants in the placebo group experienced one, compared to 238 in the denosumab group. For hip fractures specifically, 43 participants in the placebo group experienced one, compared to 26 in the denosumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00718861 · results posted 30 December 2013

  According to the results reported on ClinicalTrials.gov, this trial involved 190 participants in total — 95 in each of two groups. Both groups had previously received six years of a bone-strengthening infusion called zoledronic acid. For the next three years, one group (called Z9) continued receiving the infusion every year, while the other group (called Z6P3) switched to a dummy infusion (placebo) for those three years. The main thing the trial was measuring was how much participants' hip bone density changed between year 6 and year 9. Bone density was measured using a low-dose X-ray scan called a DXA scan. The reported data shows that, on average, both groups had a small decrease in total hip bone density between year 6 and year 9. The group that continued the active infusion (Z9) showed a reported average decrease of 0.54%, while the group that switched to placebo (Z6P3) showed a reported average decrease of 1.31%. Looking back over the full nine years from the very start of the trial, the reported data shows both groups ended with higher hip bone density than when they started — the Z9 group showed an average increase of about 4.64% and the Z6P3 group showed an average increase of about 3.68% compared to the beginning. Similar patterns were reported for bone density at the femoral neck (the top of the thigh bone where it meets the hip). A blood-based bone marker (a chemical that reflects how quickly bone is being broken down) remained at broadly similar levels across both groups throughout the follow-up period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00808132 · results posted 20 December 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,886 participants across five groups. Each group received a different treatment: two groups received a combination of bazedoxifene (20 mg) with conjugated estrogens at either a lower (0.45 mg) or higher (0.625 mg) dose; one group received bazedoxifene (20 mg) alone; one group received a different hormone combination (conjugated estrogens 0.45 mg with medroxyprogesterone acetate 1.5 mg); and one group received a placebo (an inactive dummy treatment). The trial was measuring two main things: whether the uterine lining showed abnormal thickening (called endometrial hyperplasia) after 12 months, and whether bone density in the spine changed over the same period in a smaller sub-group of participants. The reported data shows that, for the uterine lining outcome, the percentage of participants found to have abnormal thickening ranged from 0.00% (bazedoxifene alone and the hormone combination groups) to 0.85% (placebo), with the two bazedoxifene-plus-estrogen combination groups sitting at 0.30% and 0.54% respectively, under the first of two measurement definitions used. For the spine bone density sub-study, the reported average percentage change from the starting point at 12 months ranged from a decrease of 1.28% in the placebo group to increases of 0.07%, 0.24%, 0.60%, and 1.30% across the four active treatment groups. Secondary measurements included changes in hip bone density, breast density, and the proportion of participants who had no bleeding or spotting over the year — that figure (called cumulative amenorrhea) ranged from around 54% in the hormone combination group up to roughly 88% in one of the bazedoxifene-plus-estrogen groups. The reported data also shows that breast density (measured in a separate sub-group) changed by between −0.45% and −0.25% in the bazedoxifene-containing groups and the placebo group, while the conjugated estrogens/medroxyprogesterone group showed an average increase of 1.60%. These are numbers reported from the trial measurements and do not on their own tell us what those changes mean for any individual person's health. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01221727 · results posted 7 November 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total — 21 in a group that received both denosumab (a bone-related medicine) and a drug called midazolam, and 9 in a group that received midazolam only. Of those who started, 19 and 8 people respectively actually received treatment, and 18 and 8 completed the trial. The trial was measuring whether the presence of denosumab in the body changes the way midazolam is processed (absorbed and cleared) — specifically by comparing blood-concentration patterns of midazolam with and without denosumab present. The reported data shows that the main measurement used was a ratio comparing drug exposure (the total amount of the drug detected in the blood over time, known as "AUC") under the two different conditions. A ratio of 1.0 would mean no difference at all. For the group that received both medicines, the reported ratios were 1.10 and 1.12, meaning the total exposure to midazolam was measured as slightly higher when denosumab was also present. For the midazolam-only comparison group, the ratios were 0.98 and 0.98, very close to 1.0. The reported data also includes measures of how much these readings varied between different people (inter-subject variability) and within the same person on different occasions (intra-subject variability); those figures were small in both groups, though slightly higher in the denosumab group for between-person variation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00086619 · results posted 26 September 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people in total — 40 in a group receiving a constant dose of PTH (a hormone related to bone regulation) and 40 in a group receiving a gradually increasing dose of PTH. The trial was measuring two main things: changes in markers in the blood that reflect how quickly bone is being broken down and rebuilt (called bone turnover markers), and changes in bone mineral density (a measure of how dense or solid bones are) at several sites in the body, including the spine, hip, forearm, and overall body. The reported data shows that for the primary measurement — bone turnover markers tracked over time — the constant dose group had combined scores of 4,418, 956, and 22 (for three different markers), while the ascending dose group had scores of 3,696, 822, and 19 for those same markers. These numbers represent a calculated total change in each marker across the study period, rather than a single point-in-time reading. For the secondary measurement — percentage change in bone density — the reported data shows mixed results across body sites. For example, spine density appeared to decrease in both groups (−4.6% constant dose; −3.1% ascending dose), while hip density showed a small increase in both groups (1.7% and 3.5% respectively), and forearm density also showed increases (5.9% and 7.4%). These figures were only calculated for participants who received the study treatment for at least 12 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00826228 · results posted 11 July 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT00826228) enrolled 12 participants in a single group that received a combination of PTH (a bone-related hormone treatment) and a weight-bearing programme. Eleven of the 12 participants completed the study, while one did not finish. The trial was measuring changes in bone mineral density — a measure of how dense or strong bones are — as well as changes in a blood marker linked to bone building activity. The reported data shows that, on average, participants in the PTH/Weight-Bearing group had a 0.02% change in bone mineral density at the left hip from the start of the study to its end. For the secondary measure — a blood marker called P1NP, which reflects how actively the body is forming new bone — the reported data shows an average change of 61.4% from the starting point. No other outcome figures were included in the submitted results data. It is worth noting that this was a small study with only 12 participants and one group, so the numbers above reflect a very limited sample. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01077817 · results posted 1 May 2013

  According to the results reported on ClinicalTrials.gov, this study involved a very large group of approximately 684,815 female participants drawn from the General Practice Research Database in the United Kingdom. The trial was looking at whether certain medications used to treat osteoporosis (weak bones) — specifically alendronate, etidronate, ibandronate, risedronate, and raloxifene — were associated with the occurrence of oesophageal cancer (cancer of the food pipe) in women. Researchers compared women who were diagnosed with oesophageal cancer against a broader comparison group, and also tracked new users of these medications over time against women who did not start these drugs. The reported data shows that, among women diagnosed with oesophageal cancer, between 0.3% and 4.6% had been exposed to each of the individual osteoporosis drugs in the period leading up to their diagnosis, compared to between 0.03% and 2.7% in the comparison group. The reported data also shows that, when tracking cases of oesophageal cancer per 100,000 women per year, the figures were 32 cases for women who did not take any of the study drugs, 32 for alendronate users, 42 for etidronate users, 46 for ibandronate users, 47 for risedronate users, and 29 for raloxifene users. These are the raw numbers as submitted; any further interpretation of what these figures mean in terms of relative risk was not included in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00205777 · results posted 10 April 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled approximately 7,600 postmenopausal women across its core phase, with participants followed through several study extensions lasting up to seven years (84 months) in total. The trial compared two doses of a medicine called bazedoxifene and an existing medicine called raloxifene against a placebo (an inactive treatment). The main thing being measured was how many women developed new spinal (vertebral) fractures over time. A secondary measure tracked how many women were diagnosed with breast cancer during the study. The reported data shows that at the three-year (36-month) mark, around 2.0% of women taking bazedoxifene 20 mg and 2.1% taking bazedoxifene 40 mg developed a new spinal fracture, compared with 3.1% in the placebo group; the raloxifene group showed approximately 1.8%. (A second set of figures covering women who already had a fracture at the start showed slightly higher rates across all groups.) At five years (60 months), the reported figure for bazedoxifene 20 mg was about 3.1%, compared with 5.4% for placebo. At seven years (84 months), bazedoxifene 20 mg showed approximately 5.8%, compared with 8.2% for placebo. For breast cancer, the reported rates across all time points and all groups were between roughly 0.9 and 1.7 cases per 1,000 women per year — the data does not allow conclusions to be drawn about differences between groups, and the trial was not primarily designed to measure this outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01321723 · results posted 21 February 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT01321723) enrolled 97 people across three groups: 32 received Forsteo (teriparatide, given by injection), 33 received an experimental PTH analog tablet, and 32 received a placebo (an inactive treatment). The trial ran for 24 weeks and was primarily measuring changes in bone mineral density (BMD) — a measure of how dense or strong bones are — in the lower spine. It also looked at certain chemical markers in the blood that reflect how quickly bone is being broken down or built up. The reported data shows that, for the main outcome — the percentage change in lower spine bone density after 24 weeks — the Forsteo injection group showed an average increase of about 5.1%, the PTH analog tablet group showed an average increase of about 2.2%, and the placebo group showed an average change of approximately −0.2% (a very slight decrease). For the blood markers, the reported data shows the bone formation marker (P1NP, a signal of new bone being made) rose by around 210% in the Forsteo group, about 12% in the tablet group, and fell by about 1.75% in the placebo group. The bone breakdown marker (CTx-1) rose by approximately 113% in the Forsteo group, about 13% in the tablet group, and about 15% in the placebo group. A separate measurement of how much of the PTH substance was absorbed into the bloodstream showed broadly similar levels between the Forsteo group (152 pg·hr/mL) and the tablet group (165 pg·hr/mL). Regarding reported side effects, a post-hoc count (meaning it was analysed after the main study plan) recorded that 23 of 32 participants in the Forsteo group, 30 of 33 in the tablet group, and 21 of 32 in the placebo group experienced at least one adverse event; no further breakdown of those events was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00980174 · results posted 29 November 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 242 participants in total — 121 in a placebo group (a dummy treatment with no active ingredient) and 121 in a group receiving denosumab 60 mg given once every six months. The trial ran for 12 months and was primarily measuring changes in bone mineral density (a measure of how dense or strong bones are) at the lower spine, as well as at several other bone sites around the hip and wrist. It also measured a blood marker related to bone breakdown. The reported data shows that at 12 months, the lower spine bone density in the placebo group had changed by an average of +0.9%, while the denosumab group showed an average change of +5.7%. For the total hip, the reported changes were +0.3% (placebo) and +2.4% (denosumab). At the femoral neck (the top of the thigh bone), the figures were 0.0% and +2.1% respectively, while at the trochanter (another part of the hip area) they were +0.8% and +3.1%. At the distal forearm (lower wrist), the reported changes were −0.3% (placebo) and +0.6% (denosumab). For the blood marker of bone breakdown measured at day 15, the placebo group showed an average change of −7%, while the denosumab group showed an average change of −81%. The reported data also shows that 117 of 121 placebo participants and 111 of 121 denosumab participants completed the study, meaning a small number in each group did not finish. These numbers describe what was measured and recorded in this particular trial — they do not indicate whether one result is better or worse in a clinical sense for any individual person. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00525798 · results posted 18 October 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00525798) involved 4,665 participants in total — 2,334 people received the treatment (called SMC021) and 2,331 received a placebo (a dummy treatment with no active ingredient). The trial ran for three years and was looking at whether there was a difference in the number of new bone fractures — both fractures in the spine (vertebral fractures) and fractures in other parts of the body such as the hip, forearm, upper arm, ribs, and collarbone (non-vertebral fractures) — between the two groups. The reported data shows that, over the three-year period, 94 participants in the SMC021 group experienced a new spinal fracture, compared with 99 participants in the placebo group. For fractures in other parts of the body, 75 participants in the SMC021 group were reported to have had a non-vertebral fracture, compared with 82 participants in the placebo group. It is worth noting that not all participants completed the full three years — 756 people in the SMC021 group and 599 in the placebo group did not finish the study, though the reasons for this were not detailed in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00960934 · results posted 10 October 2012

  According to the results reported on ClinicalTrials.gov, this trial tested five different doses of an investigational drug called MK-5442 (2.5 mg, 5 mg, 7.5 mg, 10 mg, and 15 mg) compared to a placebo (a dummy pill with no active ingredient). A total of 383 people were enrolled across the six groups, with roughly 63–64 people in each group. The trial was measuring two main things over six months: whether the drug changed bone density in the lower spine, and whether participants' calcium levels or other specific health events (such as kidney stones or bone tumours) moved outside pre-set safety limits. The reported data shows that for bone density in the lower spine, the percentage change from the start to six months ranged from about +0.74% (lowest dose) to +1.69% (10 mg dose) across the MK-5442 groups, compared with +0.57% in the placebo group. For total hip bone density, the reported changes were small and mixed, ranging from –0.32% to +0.33% across MK-5442 doses, versus +0.08% in the placebo group. Regarding calcium levels, the reported data shows that the proportion of participants whose total blood calcium rose above the pre-set threshold (10.6 mg/dL) increased noticeably with higher doses — from about 7.8% at the lowest dose up to 73.0% at the highest dose, compared with 3.2% in the placebo group. A similar pattern was seen when calcium was measured using an adjusted calculation. The reported data shows that kidney stones were recorded in 1.6% of participants in each of the two lowest-dose groups and in none of the other groups or placebo, and no bone tumours were reported in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00068822 · results posted 27 September 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00068822) enrolled 131 participants in total — 68 were assigned to receive vertebroplasty (a procedure where a type of bone cement is injected into a fractured spinal bone) first, and 63 were assigned to a control (comparison) group first. The trial was measuring back-related disability and pain levels at one month, comparing the two groups. Some participants later had the option to cross over to the other treatment — 9 from the vertebroplasty group and 29 from the control group chose to do so. The reported data shows that for the two main ("primary") outcomes measured at one month, both groups scored fairly similarly. On the Roland-Morris Disability Questionnaire — a back disability scale running from 0 (no disability) to 23 (most severe) — the vertebroplasty group scored 12.0 and the control group scored 13.0. For average pain intensity, rated on a scale of 0 to 10 (where 10 is the worst pain), the vertebroplasty group scored 3.9 and the control group scored 4.6. The reported data also shows results for several additional ("secondary") measures of well-being at one month. On a physical health summary scale (SF-36 physical component, where higher scores out of 100 indicate better health), the vertebroplasty group scored 29.7 versus 28.7 for the control group. On the mental health summary, scores were 46.9 versus 45.6. Pain frequency and pain bothersomeness (both on a 0–4 scale, higher meaning worse) were 2.1 vs 2.3 and 1.9 vs 2.1 respectively. A quality-of-life score (EQ-5D, where 1.0 is best) was 0.70 vs 0.64, and a back-related daily activity difficulty score (0–18, higher meaning more difficulty) was 7.7 vs 8.2. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00766532 · results posted 14 September 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom were in a single group receiving aromatase inhibitor therapy. Ten participants completed the study, while two did not finish. The trial was measuring how aromatase inhibitor therapy related to the amount of calcium absorbed through the intestines — in other words, how much calcium the body was taking in from the gut. The reported data shows one primary outcome was measured: the change in intestinal calcium absorption. The result recorded for the group was 16 percent calcium absorption. No additional breakdown of the data — such as what the absorption level was before or after treatment, or how much it changed — was reported in the structured results submitted to ClinicalTrials.gov. It is worth noting that with only 12 people enrolled, this was a very small study, and the submitted results are limited in detail. No secondary outcome measures were included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT00323609 · results posted 8 August 2012

  According to the results reported on ClinicalTrials.gov, this trial compared two procedures used to treat spinal fractures caused by conditions like osteoporosis — kyphoplasty and vertebroplasty. A total of 191 people were assigned to the kyphoplasty group and 190 to the vertebroplasty group, with a smaller number of additional participants (8 and 15 respectively) who were enrolled but not treated. The trial followed participants for 12 months and measured things like new fractures showing up on X-rays, back pain levels, how much back problems affected daily functioning, and quality of life. The reported data shows that at 12 months, 64.3% of kyphoplasty participants and 56.5% of vertebroplasty participants had one or more new fractures visible on imaging. Back pain was measured on a scale of 0 (no pain) to 10 (worst pain): both groups started at around 7.7–7.8 before treatment, and both reported scores of around 3.2–3.8 at later time points. Back function was measured using a disability score from 0 (no disability) to 100 (maximum disability): both groups started around 57–59 and reported scores in the high 20s to low 30s at later time points. Quality-of-life scores also shifted across both groups over the course of the study. The reported data shows that within 30 days of the procedure, 26.2% of kyphoplasty participants and 27.4% of vertebroplasty participants experienced a serious adverse event — meaning something significant enough to require hospitalisation or medical intervention, or that was life-threatening. It is worth noting that a large number of participants did not complete the study — 91 in the kyphoplasty group and 99 in the vertebroplasty group — which the data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01078805 · results posted 26 June 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT01078805) enrolled 4,167 people who were treated with a medication called teriparatide (brand name FORTEO), which is a type of osteoporosis treatment given by injection. Of those who started, 4,085 received at least one dose, and 3,720 were included in the main analysis group. The trial ran for up to 24 months and was primarily looking at how many participants experienced a "non-vertebral fragility fracture" — that is, a broken bone (not in the spine) caused by something like a fall from standing height. It also measured spinal fractures, back and general pain levels, bone density, and how long participants stayed on the medication. The reported data shows that the percentage of participants who experienced a non-vertebral fragility fracture was reported across different time points or subgroups as 1.42%, 0.91%, 0.70%, and 0.81%. For clinical spinal fractures (breaks in the spine that caused pain and came to medical attention), the reported figures were 0.67%, 0.40%, 0.35%, and 0.35% across the same measurement points. Back pain scores, measured on a 0–100 scale where higher numbers mean more pain, showed a reported average change of −36.2% from the start of the study to 24 months. Overall pain scores showed a reported average change of −24.9% over the same period. Bone mineral density — a measure of how much mineral is in the bone — showed reported percentage changes ranging from approximately 0.6% to 6.4% depending on which part of the body was measured. Treatment adherence (how long people stayed on the medication) was reported with figures ranging from around 72 to 744 days across different groups or time points, though the data as submitted does not fully clarify what each individual figure corresponds to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00186901 · results posted 27 March 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 424 people in total — 134 in a placebo group, 141 in a supplement group (taking calcium and vitamin D), and 149 who were not eligible for randomisation and were observed separately. The trial was studying survivors of a blood cancer called Acute Lymphoblastic Leukaemia (ALL) and measuring their bone mineral density (BMD) — essentially how dense and strong their bones were. BMD was tracked at the start of the study, at 12 months, and at 24 months, using a score called a Z-score, which compares a person's bone density to what would be expected for someone of their age and sex. A score between 0 and −1 is considered a mild deficit, −1 to −2 is moderate, and below −2 is severe. The reported data shows that at the start of the study, both the placebo group and the supplement group had Z-scores of around −0.95 and −0.97 respectively — sitting in the mild-to-moderate deficit range. At 12 months, the scores were −0.87 (placebo) and −1.04 (supplement); at 24 months, −0.72 and −0.76; and by the end of the study, −0.56 and −0.61. The reported data also shows differences in bone density scores across participant subgroups: males had a score of −0.62 compared with −0.30 for females; participants identified as White had a score of −0.54 compared with +0.15 for non-White participants; and scores varied across age groups, ranging from around −0.54 to −0.60 for those aged 9–18 years, and −0.25 for those over 22. A secondary measurement compared two different bone-scanning methods and reported broadly similar Z-scores between them across both groups and time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01152580 · results posted 12 March 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 19 women in total — 5 received a sugar pill (placebo) and 14 received a 3 mg melatonin tablet taken nightly for six months. One person in the melatonin group did not complete the study. The trial was measuring whether melatonin had any effect on bone health markers and menopause-related quality of life, compared with a sugar pill. Bone health was assessed in three ways: a blood marker linked to bone-building cells (osteocalcin), a blood marker linked to bone breakdown (NTX), and a bone density scan of the heel reported as a "T-score" (a number that compares a person's bone density to that of a healthy 30-year-old woman, where a more negative number means lower bone density). Quality of life was measured using a menopause-specific questionnaire covering physical, vasomotor (for example, hot flushes), psychosocial, and sexual domains, scored on a scale where a lower change means fewer bothersome symptoms. The reported data shows the following average changes from the start of the study to six months. For the bone-building marker (osteocalcin), the sugar pill group showed a change of −0.6 ng/mL and the melatonin group showed a change of +1.83 ng/mL. For the bone breakdown marker (NTX), both groups showed small negative changes: −0.36 in the sugar pill group and −0.32 in the melatonin group. For the heel bone density T-score, the sugar pill group showed a change of −0.02 and the melatonin group showed a change of +0.05. On the quality-of-life questionnaire, the reported average changes were: physical domain −0.6 (melatonin) versus +0.1 (sugar pill); vasomotor domain +0.4 (melatonin) versus −0.2 (sugar pill); and psychosocial domain −0.4 (melatonin) versus −0.2 (sugar pill). No data was reported for the sexual domain of the quality-of-life questionnaire. It is worth noting that this was a very small trial — fewer than 20 participants across both groups — and the reported numbers simply describe what was measured and recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00439647 · results posted 16 November 2011

  According to the results reported on ClinicalTrials.gov, this trial looked at whether zoledronic acid (given as an infusion) compared to a placebo (an inactive infusion) could reduce the number of new spinal fractures in people over a 24-month period. A total of 588 people started in the zoledronic acid group and 611 in the placebo group, though slightly smaller numbers — 553 and 574 respectively — were included in the main analysis. Spinal fractures were measured using X-rays, with researchers looking at changes in the height of the bones in the spine. The reported data shows that for the main outcome — the percentage of participants who experienced at least one new spinal fracture over 24 months — 1.6% of people in the zoledronic acid group had a new fracture, compared to 4.9% in the placebo group. For the secondary outcomes, the reported data shows that over 12 months, 0.9% of the zoledronic acid group had a new spinal fracture compared to 2.8% in the placebo group. When looking only at more serious (moderate or severe) fractures, 0.4% in the zoledronic acid group versus 1.9% in the placebo group had such a fracture at 12 months, and 1.1% versus 3.0% at 24 months. The trial also measured fractures that were either new or had gotten worse: at 12 months this was 1.3% versus 2.8%, and at 24 months it was 2.0% versus 4.9%, for the zoledronic acid and placebo groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00619957 · results posted 28 October 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 285 participants across two groups — 93 people received a placebo (an inactive treatment) and 192 received risedronate, a medication used in relation to bone density. The trial was measuring changes in bone mineral density (BMD) — essentially, the density or "thickness" of bone — at the lower spine and hip over time. The study ran in two phases: a 24-month double-blind phase (where neither participants nor researchers knew who received which treatment) and a further 24-month open-label phase. Not everyone completed the full trial — 18 people in the placebo group and 17 in the risedronate group did not finish the first phase. The reported data shows that the primary measurement — the percentage change in lower spine bone density from the start of the trial to 24 months — was +1.22% in the placebo group and +5.75% in the risedronate group. At earlier time points, the reported figures were: at 6 months, +1.03% (placebo) versus +3.60% (risedronate); at 12 months, +1.42% (placebo) versus +4.60% (risedronate); and at 24 months specifically, +1.40% (placebo) versus +5.98% (risedronate). For the hip (total proximal femur), the reported changes were smaller: at 6 months, +0.76% (placebo) versus +1.16% (risedronate), and at 12 months, +0.74% (placebo) versus +1.38% (risedronate). Hip data beyond 12 months was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01249261 · results posted 26 October 2011

  According to the results reported on ClinicalTrials.gov, this trial involved 61 participants in total — 30 in one group and 31 in another. One group received a placebo first and then switched to risedronate (a bone-strengthening medicine), while the other group received risedronate throughout. The trial was measuring changes in bone density — essentially, how dense and strong the bones were — at two sites: the lower spine (lumbar spine) and the hip (femoral neck). Bone density was measured at 6 months and 12 months into the study, and all scans were reviewed centrally to keep the readings consistent. The reported data shows the following percentage changes in bone density from the starting point of the core study. For the lower spine, the group that received placebo then switched to risedronate showed an average increase of about 6.2% at 6 months and 5.5% at 12 months. The group that received risedronate throughout showed an average increase of about 12.8% at 6 months and 13.3% at 12 months. For the hip (femoral neck), the placebo/switch group showed an average change of about −1.0% at 6 months (a small decrease) and −0.3% at 12 months, while the risedronate-only group showed an average increase of about 1.5% at 6 months and 3.2% at 12 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00165698 · results posted 11 August 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 240 people in total — 120 in a group taking menatetrenone (a form of vitamin K2) and 120 in a group taking alfacalcidol (a form of vitamin D). By the end of the 12-month study, 112 people in the menatetrenone group and 105 in the alfacalcidol group had completed it. The trial was measuring changes in bone mineral density (BMD — a measure of how dense or solid bones are) and related bone markers over one year. The reported data shows the following changes in bone density after 12 months. In the lower spine (lumbar spine), BMD changed by +1.22% in the menatetrenone group and +2.17% in the alfacalcidol group. In the neck of the thigh bone (collum femoris), the change was +0.76% for menatetrenone and 0.00% for alfacalcidol. In the upper thigh bone area (trochanter), the change was +2.66% for menatetrenone and +1.76% for alfacalcidol. The trial also measured bone mineral content (BMC — the actual amount of mineral in the bone) and a bone-related protein called osteocalcin. For BMC in the lumbar spine, the reported change was +2.39% (menatetrenone) and +2.81% (alfacalcidol); in the neck of the thigh bone, it was +1.58% versus +0.95%. The osteocalcin level changed by −38.67% in the menatetrenone group and −25.77% in the alfacalcidol group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00504166 · results posted 10 August 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 53 people in total — 26 in the alendronate sodium (a bone-related medication) group and 27 in the placebo (dummy treatment) group. The trial was measuring changes in the tiny internal structure of bone, specifically something called **trabecular number** — a way of describing how closely packed the fine, lattice-like struts inside bone are. This was measured using a specialised high-resolution scanning technique at the wrist and ankle at the start of the trial and again at 12 and 24 months. By the end of the study, 20 people in the alendronate group and 13 in the placebo group had completed it. The reported data shows the results as a percentage change from each participant's starting measurement. At one time point, the alendronate group showed an average change of +2.1% in trabecular number, while the placebo group showed an average change of −0.6%. At the other time point, the alendronate group showed an average change of +0.9%, compared with +4.1% in the placebo group. It is worth noting that the data as submitted does not clearly label which of these two sets of figures corresponds to the 12-month or 24-month measurement, so the exact timing of each result cannot be confirmed from the available information. It is also worth noting that a notable number of participants did not complete the trial — 6 in the alendronate group and 14 in the placebo group — and no secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00404820 · results posted 1 July 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 408 people in the zoledronic acid group (a once-yearly intravenous, or drip, infusion) and 196 people in the alendronate group (a weekly tablet), giving a total of 604 participants. The trial ran for 12 months and was primarily measuring changes in a bone-activity marker in the blood called NTx — a substance that can rise when bone is breaking down more quickly. Several secondary measurements were also tracked, including another bone-activity marker called P1NP, quality of life, the number of clinical fractures recorded, changes in height, and which type of treatment participants said they preferred at the end of the study. The reported data shows that over the 12-month period, the average NTx level (the primary measure) was 0.282 ng/ml in the zoledronic acid group and 0.270 ng/ml in the alendronate group. For the secondary bone marker P1NP, the reported averages were 28.2 ng/ml and 25.5 ng/ml respectively. On the quality-of-life questionnaire (where a lower score means better quality of life, and a negative change means improvement), the zoledronic acid group showed a change of −1.2 points and the alendronate group showed a change of −0.6 points from the start of the study. The reported data shows that 10 participants in the zoledronic acid group and 4 in the alendronate group were recorded as having a clinical fracture during the study. Average height change was −0.1 cm in the zoledronic acid group and 0.0 cm in the alendronate group. Regarding treatment preference, the reported data shows that 30 people in the zoledronic acid group and 16 in the alendronate group said they preferred weekly oral therapy, while 330 versus 82 said they preferred the yearly infusion, and 48 versus 93 expressed no preference or another response. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00247273 · results posted 21 June 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 644 women in the daily 5 mg risedronate group and 650 women in the once-monthly 150 mg risedronate group — a total of 1,294 participants with postmenopausal osteoporosis (reduced bone density after menopause). The trial was measuring changes in bone mineral density (BMD) — essentially how dense or strong the bones of the lower spine were — over 12 and 24 months, comparing a daily tablet dose to a once-monthly tablet dose of the same medication. Around 498 and 513 participants in each group respectively completed the study. The reported data shows that at 12 months, the lower spine BMD increased by approximately 3.4% in the daily 5 mg group and 3.5% in the monthly 150 mg group. At 24 months, the reported figures were approximately 4.2% and 4.3% respectively. When measured in absolute bone density units (g/cm²) rather than percentages, the reported changes at 12 months were 0.026 g/cm² for the daily group and 0.026 g/cm² for the monthly group, and at 24 months were 0.031 g/cm² and 0.032 g/cm² respectively. These numbers represent the average changes recorded across all participants in each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00551174 · results posted 30 May 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 781 people in total — 381 in a group receiving a 2 mg dose of ibandronate (a bone medicine) every two months, and 400 receiving a 3 mg dose every three months. The trial was measuring changes in bone density (a measure of how dense and strong bones are) at the lower spine and hip over 12, 24, and 36 months. It also tracked a blood marker called CTX, which gives an indication of how quickly the body is breaking down bone tissue. The reported data shows that, for lower spine bone density, both groups showed small increases from their starting point over time. By 36 months, the 2 mg group showed a reported change of approximately +1.98%, and the 3 mg group approximately +2.06%. For total hip bone density, the reported changes were much smaller and appeared to decrease slightly over time — by 36 months, the 2 mg group showed approximately −0.15% and the 3 mg group approximately −0.26% compared to their starting values. For the CTX blood marker at trough (meaning measured just before the next dose was due), both groups showed increases from baseline across the timepoints reported — rising to around +41% and +58% respectively by 36 months. At 6 months, when CTX was measured shortly after a dose was given (post-dose), the reported changes were approximately −78% in the 2 mg group and −82% in the 3 mg group compared to baseline. The reported data shows results across two dose schedules, but this summary describes only the numbers as submitted — it does not indicate which approach, if either, is preferable for any individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00803790 · results posted 9 May 2011

  According to the results reported on ClinicalTrials.gov, this trial involved 318 participants split across two parts. Part 1 included 251 people and compared a combined tablet containing alendronate (a bone medicine) and vitamin D against an alendronate-only tablet. Part 2 included 67 people and compared the same combination tablet against a vitamin D-only tablet. The trial was designed to test whether the combination tablet delivered the same amount of each medicine into the body as the individual tablets given separately — this type of study is called a bioequivalence study. The reported data shows that in Part 1, the total amount of alendronate measured in urine over 36 hours was 133.6 micrograms for people who took the combination tablet, compared with 132.2 micrograms for those who took the alendronate-only tablet. In Part 2, the total absorption of vitamin D (measured by tracking how the level in the blood rose and fell over 80 hours) was reported as 490.2 ng·hr/mL for the combination tablet group and 518.7 ng·hr/mL for the vitamin D-only group. The reported data also shows that the peak vitamin D level reached in the blood was 12.2 ng/mL for the combination tablet and 13.0 ng/mL for the vitamin D-only tablet. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00145327 · results posted 20 April 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,456 participants across three groups. All participants had previously completed three years of treatment with zoledronic acid (a medication given by infusion, commonly used in bone conditions). The trial then looked at what happened over the next three years depending on whether people continued the medication, stopped it, or started it for the first time. The three groups were: those who received zoledronic acid for all six years ("ZA 6"); those who received it for the first three years and then switched to a placebo (an inactive dummy infusion) for the next three years ("ZA 3 / Placebo 3"); and those who received a placebo for the first three years and then switched to zoledronic acid for the next three years ("Placebo 3 / ZA 3"). The main thing being measured was the change in bone mineral density (BMD) — a measure of how dense or strong bones are — at the femoral neck (the top of the thigh bone near the hip) between year three and year six. The reported data shows that, for the primary measure — percentage change in femoral neck BMD from year three to year six — the group who took zoledronic acid for all six years showed a reported change of approximately +0.6%. The group who stopped after three years and switched to placebo showed a reported change of approximately −0.5% (a slight decrease). The group who had been on placebo and then started zoledronic acid showed a reported change of approximately +3.3%. For bone density at the lower spine (lumbar spine) measured at year six compared to year three, the reported figures were approximately +3.5% for the continuous six-year group, +1.6% for the group that stopped after three years, and +8.9% for the group that started zoledronic acid in year four. The trial also measured a blood marker called P1NP (a protein that reflects how actively the body is building bone), with reported levels at year six of approximately 27 ng/mL, 30 ng/mL, and 26 ng/mL across the three groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00771758 · results posted 7 April 2011

  According to the results reported on ClinicalTrials.gov, this trial compared three treatments for pain: tapentadol IR (an immediate-release pain medicine), oxycodone IR (another immediate-release pain medicine), and a placebo (a dummy pill with no active ingredient). A total of 108 people took part — 44 in the tapentadol group, 43 in the oxycodone group, and 21 in the placebo group. The trial was originally planned to enrol 600 people, but it was stopped early because not enough people were signing up. As a result, the researchers noted that firm conclusions cannot be drawn from the numbers due to the small number of participants. The main thing the trial measured was a score called SPID72 — essentially a running total of how much participants' pain ratings changed from their starting level over 72 hours (3 days), where a higher number means a bigger reported reduction in pain scores. The reported data shows the tapentadol group scored 139.0, the oxycodone group scored 129.4, and the placebo group scored 114.2, all on a scale that can range from -720 to 720. The trial also tracked what proportion of participants reported their pain dropping by at least 30% or at least 50% from their starting level at days 3, 5, and 10. The reported data shows that at day 3, roughly 36% of the tapentadol group, 39% of the oxycodone group, and 50% of the placebo group reported a 30% or greater reduction in pain. For a 50% or greater reduction at day 3, the figures were approximately 25%, 24%, and 25% respectively. Similar patterns were seen at days 5 and 10, with no striking differences between the groups across these measures. It is important to keep in mind that, as the researchers themselves stated, the trial enrolled far fewer people than planned, meaning these numbers should be interpreted with great caution and no reliable statistical comparisons between groups can be made from this data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00918749 · results posted 24 March 2011

  According to the results reported on ClinicalTrials.gov, this trial compared three different doses and formulations of a medicine called risedronate, used in bone health research. A total of 205 people started the trial across three groups: 70 people received a 150 mg immediate-release tablet (taken once a month), 66 received a 75 mg delayed-release tablet, and 69 received a 100 mg delayed-release tablet. The trial was measuring changes in two natural markers found in blood and urine that reflect how quickly bone tissue is breaking down — one called CTX (measured in blood) and another called NTX (measured in urine). These markers were tracked at months 2, 3, and 4 of the study. The reported data shows that at the four-month mark — the trial's main measurement point — all three groups had lower blood CTX levels compared to where they started. The 150 mg group showed a reported average reduction of about 41%, the 75 mg group about 45%, and the 100 mg group about 53%. At the earlier time points (months 2 and 3), the reported reductions in blood CTX were broadly similar across the three groups, ranging roughly from 34% to 46%. For the urine NTX marker, the reported data shows more variation between groups, particularly at month 2, where the 150 mg group showed a reduction of about 15%, while the 75 mg and 100 mg groups showed very small reductions of less than 2%. By months 3 and 4, the reported reductions in urine NTX were somewhat closer across the groups, ranging from approximately 8% to 29%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00431444 · results posted 11 March 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 109 participants in total — 56 in the zoledronic acid group and 53 in the raloxifene group. The trial was comparing the two treatments in terms of their effect on certain markers found in urine and blood that are associated with bone turnover (the natural process of bone being broken down and rebuilt). The main thing the trial measured was a urine marker called NTx (a substance released when bone breaks down), with the key measurement point being at 6 months. It also tracked the same marker at 2 and 4 months, as well as a blood marker called BSAP (a protein linked to bone activity), at 2, 4, and 6 months. By the end of the study, 51 participants in the zoledronic acid group and 46 in the raloxifene group had completed the trial. The reported data shows that, for the primary outcome — the change in the urine NTx marker at 6 months — the zoledronic acid group started at an average of about 49.1 units and came down to about 23.7 units, a reported change of approximately −24.6 units. The raloxifene group started at roughly 44.5 units and came down to about 34.2 units, a reported change of approximately −8.4 units. For the secondary outcomes, the reported data shows a similar pattern at 2 and 4 months, with the zoledronic acid group showing larger reported reductions in the urine NTx marker than the raloxifene group at both time points. For the blood marker BSAP, the zoledronic acid group also showed larger reported reductions at 2, 4, and 6 months compared to the raloxifene group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00361595 · results posted 14 January 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 35 participants, all of whom completed the study — none dropped out. The trial had a single open-label group, meaning everyone received the same treatment and both the participants and researchers knew what was being given. The study was measuring changes in bone density (how dense and strong bones are) and certain markers in the blood that reflect bone activity, over a 12-month period. Bone density was measured using a specialised scan called DXA (a low-dose X-ray that measures bone mineral content). The reported data shows that, on average, bone mineral density at the lower spine increased by 2.2 grams per square centimetre (g/cm²) from the start of the study to month 12. At the hip, the reported average change in bone density at 12 months was 2.4 g/cm². The trial also tracked two blood markers that reflect how actively bone is being broken down and rebuilt. One marker, called CTX (a sign of bone being broken down), showed a reported average change of −49.1 nanograms per millilitre (ng/ml) at 12 months — meaning the measured level was lower than at the start. The other marker, called P1NP (a sign of bone being built), showed a reported average change of −66.2 micrograms per millilitre (mcg/ml) at 12 months, also lower than at the start. No further breakdown of results by time point (such as day 10 or months 2, 6, or 9) was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00132808 · results posted 10 January 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 581 participants across two groups (called Stratum I and Stratum II), which likely reflected different participant characteristics at the start of the study. Participants were randomly assigned to one of three groups: a double dose of zoledronic acid (two infusions of 5 mg), a single dose of zoledronic acid (one infusion of 5 mg), or a placebo (an inactive treatment). The trial ran for 24 months and was primarily measuring changes in bone mineral density (BMD) — a measure of how dense or strong bones are — at the lower spine, hip, and femoral neck (the top of the thigh bone where it meets the hip). The reported data shows that, at the lower spine after 24 months, participants in the double-dose group had an average increase in BMD of around 4.6% to 5.6% (varying by stratum), and those in the single-dose group showed an increase of around 4.0% to 4.8%, while the placebo group showed a decrease of around 0.7% to 2.2%. Similar patterns were reported at the hip and femoral neck, where both zoledronic acid groups showed increases of roughly 2–3%, compared to decreases of around 1–2% in the placebo group. The reported data also shows that blood markers used to measure bone turnover — including b-CTx, P1NP, and BSAP — were lower in both zoledronic acid groups compared to the placebo group across the measurement points at 6, 12, 18, and 24 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00259298 · results posted 11 August 2010

  According to the results reported on ClinicalTrials.gov, this trial (NCT00259298) enrolled 12 participants, all of whom were assigned to receive teriparatide. Ten participants received at least one dose of the study drug, and nine completed the trial. The study was measuring changes in how the skeleton processes a radioactive tracer called 99m Tc-MDP, which is used in bone scans to assess bone activity. By tracking how much of this tracer the skeleton absorbed and cleared from the bloodstream, the researchers aimed to see how bone activity changed over the course of treatment and after a six-month withdrawal period. The reported data shows that the primary outcome — the change in how efficiently the whole skeleton cleared the tracer from the blood over 18 months — was recorded as a 33.75% change from the starting point for the teriparatide group. For the secondary outcomes, the reported data shows varying percentage changes in tracer clearance and uptake across different parts of the skeleton (such as the skull, spine, pelvis, and limbs), with individual figures ranging widely — for example, from around −38% to +128% depending on the body region and time point measured. On a visual scoring scale of 0 to 4 used to assess localised areas of bone activity, average scores remained very low (around 0 to 0.1). For the measure looking at broader, more widespread bone activity, the reported data shows that at various time points, the majority of participants (up to 8 out of the group assessed) were classified as showing a "possible response," with smaller numbers classified under other categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00043186 · results posted 28 July 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 412 participants across nine groups. Eight groups received different doses and dosing schedules of a medicine called denosumab (ranging from 6 mg to 210 mg, given either every three or every six months), one group received a placebo (a dummy treatment with no active ingredient), and one group received an existing bone medicine called alendronate (70 mg weekly). The trial's main focus was measuring changes in bone density in the lower spine (lumbar spine) over 12 months, using a type of scan called a DEXA scan. It also tracked two substances found in blood and urine that are linked to how quickly bone is being broken down in the body. The reported data shows that at 12 months, the placebo group's lumbar spine bone density had changed by about −0.8% from where it started, while the various denosumab groups showed changes ranging from about +3.0% to +6.7%, and the alendronate group showed a change of about +4.6%. At 24 months, the placebo group was at around −1.3%, denosumab groups ranged from about +3.9% to +8.8%, and the alendronate group was at about +6.1%. At 36 months, the placebo group was at around −1.8%, most denosumab groups ranged from about +8.0% to +10.6% (with two higher-dose groups showing smaller figures of around +0.9% to +1.9%), and the alendronate group was at about +4.7%. For the blood and urine bone-breakdown markers measured at 12 months, the placebo group showed little change, while the denosumab and alendronate groups all showed reductions ranging from roughly 2% to 87%, depending on the group and the marker measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00343252 · results posted 12 July 2010

  According to the results reported on ClinicalTrials.gov, this trial compared two medicines — teriparatide and risedronate — in people with back pain, measuring whether participants experienced a meaningful reduction in their back pain over time. A total of 361 people were assigned to the teriparatide group and 351 to the risedronate group, making 712 participants in all. The trial tracked back pain using a daily diary where participants rated their worst and average back pain on a scale from 0 (no pain) to 10 (worst possible pain). The main thing the trial was looking for was how many people in each group had their worst back pain drop by at least 30% from their starting level by the 6-month mark. The reported data shows that at the 6-month point, out of 206 teriparatide participants and 193 risedronate participants who were assessed for worst back pain, 142 in the teriparatide group and 143 in the risedronate group met that 30%-reduction threshold. At 12 months, out of 233 teriparatide and 220 risedronate participants assessed, 115 and 116 respectively reached that same threshold. For average (rather than worst) back pain, the reported data shows similar patterns: at 6 months, 126 of 221 teriparatide participants and 125 of 211 risedronate participants showed at least a 30% reduction, and at 12 months, 101 of 246 and 98 of 238 respectively did so. The trial also tracked how quickly participants first reached that 30% pain reduction, with numbers building gradually across both groups over the months of follow-up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00112437 · results posted 13 May 2010

  According to the results reported on ClinicalTrials.gov, this trial investigated a drug called odanacatib at several different doses (3 mg, 10 mg, 25 mg, and 50 mg) compared to a placebo (a dummy treatment with no active ingredient) in postmenopausal women. The trial was studying how the drug affected bone mineral density — a measure of how dense and strong bones are — primarily at the lumbar spine (the lower back). The study began as a 12-month trial, but was extended in stages, eventually running for up to 10 years in total. In the first year, 399 participants were enrolled across the five groups; smaller numbers continued through the various extension phases, with the final extension period involving around 117 participants across four groups. The reported data shows that the primary outcome being measured was the percentage change in bone mineral density at the lumbar spine after 12 months. Across all groups receiving odanacatib, the reported changes in lumbar spine bone mineral density were in the positive direction (meaning density appeared to increase), with the reported figures varying by dose. The placebo group showed little to no change, or a slight decrease. Secondary outcomes tracked bone density at other sites such as the hip, as well as markers in blood and urine that indicate how quickly bone is being broken down or built up. The reported data shows that these bone turnover markers also showed dose-related differences between the odanacatib groups and the placebo group. Some outcome measure details were not fully reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00729651 · results posted 2 April 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 343 participants in total — 173 in the "Fosamax Plus D" group and 170 in the "Fosamax" group. Of those, 154 and 152 participants respectively completed the study. The trial was measuring levels of vitamin D in the blood (specifically a form called 25-hydroxyvitamin D, or 25 OHD) after 16 weeks of treatment, as well as levels of a hormone called PTH (parathyroid hormone), which the body uses to regulate calcium. The reported data shows that for the main outcome — the number of participants whose vitamin D blood level fell below a low threshold (less than 15 ng/ml, a unit used to measure concentration in the blood) at 16 weeks — 2 out of 134 participants in the Fosamax Plus D group were below that level, compared with 55 out of 77 in the Fosamax-only group. For the secondary outcome, PTH levels changed from the starting point by an average of about 8% in the Fosamax Plus D group and about 30% in the Fosamax-only group. Two additional post-hoc measurements (meaning these were not part of the original plan but were looked at afterwards) were also reported: using a slightly higher cut-off of 20 ng/ml, 7 out of 136 Fosamax Plus D participants were below that level compared with 93 out of 132 in the Fosamax group; and average vitamin D blood levels at 16 weeks were reported as 30.08 ng/ml for Fosamax Plus D and 17.14 ng/ml for Fosamax alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00715676 · results posted 11 January 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 156 participants across three groups: 49 received a placebo (an inactive treatment), 54 received a lower dose (220 ng) of a vitamin D-like compound called DP001, and 53 received a higher dose (440 ng) of DP001. The trial ran for 52 weeks and was primarily measuring changes in bone density in the lower spine. It is worth noting that a large number of participants did not complete the study — particularly in the higher-dose group, where 32 out of 53 people did not finish. The reported data shows that, after 52 weeks, spine bone density changed by −0.537% in the placebo group, −0.174% in the lower-dose group, and +0.309% in the higher-dose group (a small increase). For hip bone density, all three groups showed small decreases: −0.315% (placebo), −0.540% (lower dose), and −0.887% (higher dose). Similarly, bone density at two other hip sites (the femoral neck and trochanter) also showed small decreases across all groups. Blood calcium levels — another measurement taken — changed by −0.06 mg/dL in the placebo group, +0.11 mg/dL in the lower-dose group, and +0.29 mg/dL in the higher-dose group. The trial also measured certain markers in the blood related to bone activity at the halfway point (week 26), and the reported data shows these markers changed to varying degrees across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00620854 · results posted 24 September 2009

  According to the results reported on ClinicalTrials.gov, this trial involved 24 participants in total (four people in each of six groups). It was a crossover study, meaning everyone took all three treatments being compared — just in a different order. The three treatments were two versions of a recombinant salmon calcitonin tablet (called rsCT A, containing 150 micrograms, and rsCT B, containing 200 micrograms) and an existing calcitonin nasal spray called Fortical®. Between each treatment, participants went through a "washout" period — a rest phase to clear the previous treatment from their body before starting the next one. Two participants dropped out after the first washout period, so 22 people completed the full trial. The trial was measuring how much each treatment caused a drop in a blood marker called CTx-1 (a protein fragment linked to bone breakdown), as a way of comparing how much of the active ingredient was being absorbed and acting in the body. The reported data shows that all three treatments were associated with a fall in CTx-1 levels from where they started. The rsCT A tablet (150 micrograms) was linked to an average drop of about 74% in CTx-1. The rsCT B tablet (200 micrograms) was associated with an average drop of around 72%. The Fortical® nasal spray was associated with an average drop of roughly 68%. No secondary outcome measure data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00577863 · results posted 24 June 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 200 people in total — 92 who were already using a medication delivery pen called the Forteo 1.1 Pen ("Current Users") and 108 who were not currently using it ("Not Current Users"). The trial was measuring how many complaints people reported after using a newer version of the injection pen, called the Forteo B Pen, over 8 weeks. It also asked people who had switched from the older pen to the newer one how they felt about using it. A total of 176 people completed the study (82 Current Users and 94 Not Current Users). The reported data shows that, among people using the Forteo B Pen, 31 out of the participants who received at least one injection reported at least one complaint about the pen over the 8 weeks. In total, 47 individual complaints were recorded across those users. Of these, 19 participants reported complaints related to the device not working as expected (called "functional" complaints, totalling 27), and 14 participants reported complaints about appearance or perception of the pen (called "nonfunctional" complaints, totalling 16). Smaller numbers within those categories were also reported, but the data does not provide labels for each individual sub-complaint figure beyond what is described here. The reported data also shows responses from people who switched from the older pen to the newer Forteo B Pen, who were asked to compare the two through a questionnaire. Across several questions — including overall preference, learning to use the pen, setting the dose, and attaching a new needle — the largest group of respondents in each category chose the response most favourable to the Forteo B Pen (79, 75, 79, and 46 participants respectively out of 92), though some participants also selected neutral or favourable responses toward the older pen. The specific labels for each response option were not included in the data provided to ClinicalTrials.gov, so the exact meaning of each number cannot be described further here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.