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NCT02186171 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
NCT02186171: Completed Phase 3 study, sponsored by Amgen.
NCT02186171 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 245 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02186171, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
Study 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.
Primary Outcome
Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
Interventions
- DRUG Placebo
- BIOLOGICAL Romosozumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2014-06-16 |
| Est. Completion | 2016-04-20 |
| Phase | Phase 3 |
What the finished NCT02186171 record still lists
NCT02186171 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02186171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02186171 about?
NCT02186171 is a clinical study titled "A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis". 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...
What is the current status of trial NCT02186171?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2014-06-16. Estimated completion is 2016-04-20.
What interventions are being tested in trial NCT02186171?
The interventions under investigation include: Placebo (DRUG), Romosozumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02186171?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02186171's enrollment target sits among peer trials
245 1267th of 2000 higher than 732 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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