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NCT01081678 · ClinicalTrials.gov registry record · Phase 2
Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 332
- Enrollment target
NCT01081678: Completed Phase 2 study, sponsored by Amgen.
NCT01081678 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 332 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01081678, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 332 participants
- Enrollment target
Study 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.
Primary Outcome
Functional healing was measured by the timed-up-and-go test (TUG) over Weeks 6 through 20. During this assessment, the clinician timed the participant while they stood up from a seated position in a chair, walked three meters, turned around, walked three meters back to the chair, and returned to the seated position. A TUG value of ten seconds or less was considered normal for a healthy elderly person. Higher TUG values after hip fracture have been shown to be a predictor of future falls. Least
Interventions
- DRUG Placebo
- DRUG Romosozumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2010-06-20 |
| Est. Completion | 2013-05-10 |
| Phase | Phase 2 |
What the finished NCT01081678 record still lists
NCT01081678 is an interventional study that assigns participants to a tested intervention. The registered 332 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 (150% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01081678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01081678 about?
NCT01081678 is a clinical study titled "Study To Assess FRacTure Healing With SclerosTin Antibody - Hip". 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.
What is the current status of trial NCT01081678?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 332 participants. The study started on 2010-06-20. Estimated completion is 2013-05-10.
What interventions are being tested in trial NCT01081678?
The interventions under investigation include: Placebo (DRUG), Romosozumab (DRUG).
Who is sponsoring clinical trial NCT01081678?
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 NCT01081678's enrollment target sits among peer trials
332 144th of 2000 higher than 1,856 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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