Trials / Completed
CompletedNCT00907296
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 402 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Romosozumab | Administered by subcutaneous injection |
| DRUG | Placebo | Administered by subcutaneous injection |
Timeline
- Start date
- 2009-09-02
- Primary completion
- 2012-03-06
- Completion
- 2013-05-10
- First posted
- 2009-05-22
- Last updated
- 2022-09-22
- Results posted
- 2019-05-01
Locations
103 sites across 23 countries: United States, Australia, Bulgaria, Canada, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Latvia, Lithuania, Mexico, New Zealand, Norway, Poland, Romania, Russia, Slovakia, United Kingdom
Source: ClinicalTrials.gov record NCT00907296. Inclusion in this directory is not an endorsement.