Phase 3
Completed N=245
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
Osteoporosis in Men
Source: ClinicalTrials.gov NCT02186171 ↗
Enrolled (actual)
245
Serious AEs
13.5%
Results posted
May 2019
Primary outcomePrimary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12 — 1.2; 12.1 percent change — p=< 0.0001
◆ Published Evidence
Highly cited
315citations · ~39 / year
A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis.
Summary
The study is designed to evaluate if treatment with romosozumab once a month for 12 months compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar spine. Additionally, the study will assess the effect of treatment with romosozumab for 12 months compared with placebo on BMD at the femoral neck and total hip.
Linked Publications
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A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12 |
1.2; 12.1 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in BMD at the Total Hip at Month 12 |
-0.5; 2.5 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in BMD at the Femoral Neck at Month 12 |
-0.2; 2.2 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine BMD at Month 6 |
0.3; 9.0 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in BMD at the Total Hip at Month 6 |
0.2; 1.6 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in BMD at the Femoral Neck at Month 6 |
0.0; 1.2 | = 0.0033 sig |
Eligibility Criteria
Inclusion Criteria
- Must be ambulatory male subjects ≥ 55 years to ≤ 90 years of age
- Must have a BMD T score ≤ -2.50 at the spine or hip, or BMD T score ≤ -1.50 at the spine or hip and a history of fragility nonvertebral fracture or vertebral fracture.
Exclusion Criteria
- A BMD T score ≤ -3.50 at the hip,
- History of hip fracture
- Severe metabolic bone diseases
- Significant laboratory abnormalities
- Recent treatment with agents affecting bone metabolism
Data sourced from ClinicalTrials.gov (NCT02186171) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.