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 enrolled 34 people in total — 18 received zoledronic acid (a medication given by infusion) and 16 received a placebo (an inactive substance). The trial was designed to measure changes in bone density in the lower spine over 12 months, using a standardised score called a "Z-score" (a way of comparing a person's bone density to others of a similar age and sex). Bone mineral content (BMC, a measure of the amount of mineral in the bones) and certain blood markers related to bone activity were also tracked at 6 and 12 months. The reported data shows that, for the main outcome — change in lower spine bone density Z-score at 12 months — the zoledronic acid group had an average increase of 0.582 Z-score units, while the placebo group had an average increase of 0.168 units. At 6 months, the reported increases were 0.447 for the zoledronic acid group and 0.157 for the placebo group. For bone mineral content in the lower spine, the reported data shows average increases of 4.11 grams (zoledronic acid) versus 2.13 grams (placebo) at 6 months, and 6.45 grams versus 4.30 grams at 12 months. For total body bone mineral content, the reported figures were 129.3 grams versus 95.2 grams at 6 months, and 220.8 grams versus 140.1 grams at 12 months. Two blood markers of bone activity — P1NP and BSAP — showed average decreases in the zoledronic acid group and average increases in the placebo group at both 6 and 12 months, though what this means clinically is not described 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 34228102) ↗
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.
Phase 3 Muscular Dystrophy Trial, Completed
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 have been diagnosed with a chronic rheumatological condition (such as arthritis), inflammatory bowel disease, or Duchenne muscular dystrophy, and have needed steroid medication (by mouth or by drip) at some point in the past 12 months
- Your bone density scan of the lower spine shows results that are below the normal range (a Z-score of -0.5 or worse)
- You have had at least one spinal compression fracture within the past month, OR one or more broken bones in the lower arms or legs caused by a minor injury within the past 2 years, OR two or more broken bones in the upper arms caused by a minor injury within the past 2 years
- You (or your parent/guardian if applicable) agree to take part in the study
Who may not be able to join:
- You have a history of a primary bone disease, such as Osteogenesis Imperfecta, Idiopathic Juvenile Osteoporosis, or Rickets
- You have a condition such as severe curvature of the spine or spinal fusion that could affect how bone density is measured in the lower spine
- You have low levels of calcium or phosphate in your blood
- Your vitamin D levels are too low (below 20 ng/mL or 50 nmol/L)
- Your kidneys are not working well enough (confirm with trial site)
- Your kidney function markers showed a significant worsening between your first and second appointments (confirm with trial site)
- You have uncontrolled heart failure or an irregular heartbeat
- You have previously used medications called bisphosphonates, or have taken high-dose sodium fluoride
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.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Australian sites
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.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.