Phase 3 Osteoporosis Trial, Completed (NCT01631214)

Phase 3 Osteoporosis Trial, Completed NCT01631214 Sponsor: Amgen Condition: Osteoporosis

Printed from Voxsanity (voxsanity.com.au) — NCT01631214 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Osteoporosis

Trial 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

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.

View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38573517) ↗

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Who may be able to join

AI generated eligibility 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

Who might be able to join this trial:

You are a woman who has gone through menopause
Your bone density scan (at the hip) shows a T-score of -2.50 or lower, AND you have had at least one moderate or severe spinal (vertebral) fracture, OR at least two mild spinal fractures
Your bone density scan (at the hip) shows a T-score of -2.50 or lower, AND you have had at least two moderate or severe spinal fractures, OR a hip fracture that happened between 3 and 24 months before joining the trial
Your bone density scan (at the hip) shows a T-score of -2.00 or lower, AND you meet one of the fracture conditions described above (confirm with trial site for exact combination that applies to you)

Who may not be able to join:

You have a history of a bone or metabolism-related disease, other than osteoporosis
You are currently taking any medicines or supplements that affect bone health
You have low levels of vitamin D in your body
You have previously had an organ transplant or bone marrow transplant
Your blood calcium levels are too high or too low
Your thyroid gland is overactive or underactive
Your parathyroid glands are overactive or underactive
You have shown any signs that you cannot tolerate the medication alendronate (a common bone-strengthening drug)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: MD, Amgen

Australian sites

Research Site, Darlinghurst, New South Wales

Research Site, Kogarah, New South Wales

Research Site, Randwick, New South Wales

Research Site, Box Hill, Victoria

Research Site, Geelong, Victoria

Research Site, Heidelberg West, Victoria

Research Site, Parkville, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT01631214

Sponsor: Amgen

Phase: Phase 3

Status: Completed

Condition: Osteoporosis

More information: https://clinicaltrials.gov/study/NCT01631214

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You are a woman who has gone through menopause
Your bone density scan (at the hip) shows a T-score of -2.50 or lower, AND you have had at least one moderate or severe spinal (vertebral) fracture, OR at least two mild spinal fractures
Your bone density scan (at the hip) shows a T-score of -2.50 or lower, AND you have had at least two moderate or severe spinal fractures, OR a hip fracture that happened between 3 and 24 months before joining the trial
Your bone density scan (at the hip) shows a T-score of -2.00 or lower, AND you meet one of the fracture conditions described above (confirm with trial site for exact combination that applies to you)

Who may not be able to join:

You have a history of a bone or metabolism-related disease, other than osteoporosis
You are currently taking any medicines or supplements that affect bone health
You have low levels of vitamin D in your body
You have previously had an organ transplant or bone marrow transplant
Your blood calcium levels are too high or too low
Your thyroid gland is overactive or underactive
Your parathyroid glands are overactive or underactive
You have shown any signs that you cannot tolerate the medication alendronate (a common bone-strengthening drug)

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Phase 3

Sponsor

Amgen

Registry

ClinicalTrials.gov

Start date

4 May 2012

Est. completion

27 February 2017

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇴 Colombia 🇨🇿 Czechia 🇩🇰 Denmark Dominican Republic 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Guatemala Hong Kong 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇿 New Zealand 🇳🇴 Norway 🇵🇪 Peru 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants With New Vertebral Fractures Through Month 24; Percentage of Participants With a Clinical Fracture at the Primary Analysis

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov