Trials / Completed
CompletedNCT01081678
Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults With a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 332 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 55 Years – 95 Years
- Healthy volunteers
- Not accepted
Summary
This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Administered by subcutaneous (under the skin) injection |
| DRUG | Romosozumab | Administered by subcutaneous injection |
Timeline
- Start date
- 2010-06-20
- Primary completion
- 2012-06-30
- Completion
- 2013-05-10
- First posted
- 2010-03-05
- Last updated
- 2022-09-21
- Results posted
- 2019-05-02
Locations
99 sites across 24 countries: United States, Argentina, Australia, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, Germany, Greece, Hong Kong, Hungary, India, Italy, Latvia, Lithuania, Netherlands, New Zealand, Poland, Slovenia, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01081678. Inclusion in this directory is not an endorsement.