Trials / Completed
CompletedNCT02186171
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 245 (actual)
- Sponsor
- Amgen · Industry
- Sex
- Male
- Age
- 55 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Romosozumab | Administered by subcutaneous injection once a month. |
| DRUG | Placebo | Administered by subcutaneous injection once a month. |
Timeline
- Start date
- 2014-06-16
- Primary completion
- 2016-02-15
- Completion
- 2016-04-20
- First posted
- 2014-07-10
- Last updated
- 2019-05-28
- Results posted
- 2019-05-28
Locations
34 sites across 10 countries: United States, Belgium, Colombia, Czechia, Denmark, Japan, Mexico, Poland, Russia, Switzerland
Source: ClinicalTrials.gov record NCT02186171. Inclusion in this directory is not an endorsement.