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NCT00907296 · ClinicalTrials.gov registry record · Phase 2
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 402
- Enrollment target
NCT00907296: Completed Phase 2 study, sponsored by Amgen.
NCT00907296 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 402 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00907296, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 402 participants
- Enrollment target
Study 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).
Primary Outcome
Time to radiographic healing was defined as the time from intramedullary (IM) nailing to the first occurrence of bridging of 3 out of 4 cortices. Radiographic fracture healing was determined by a panel of independent reviewers (orthopedic/trauma surgeons and radiologists) blinded to treatment. The cumulative incidence function (CIF) method was used to estimate the median time to radiographic healing and the confidence intervals. Unplanned revision surgery to promote healing was considered a com
Interventions
- DRUG Placebo
- BIOLOGICAL Romosozumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2009-09-02 |
| Est. Completion | 2013-05-10 |
| Phase | Phase 2 |
What the finished NCT00907296 record still lists
NCT00907296 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (202% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00907296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00907296 about?
NCT00907296 is a clinical study titled "Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing". 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).
What is the current status of trial NCT00907296?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 402 participants. The study started on 2009-09-02. Estimated completion is 2013-05-10.
What interventions are being tested in trial NCT00907296?
The interventions under investigation include: Placebo (DRUG), Romosozumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00907296?
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 NCT00907296's enrollment target sits among peer trials
402 96th of 2000 higher than 1,905 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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