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NCT04249232 · ClinicalTrials.gov registry record · Phase 2
Abaloparatide and Pelvic Fracture Healing
A Phase 2 study of Fracture of Pelvis (Disorder), sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 3
- Study locations
NCT04249232: Completed Phase 2 study of Fracture of Pelvis (Disorder), sponsored by Hospital for Special Surgery, New York.
NCT04249232 is a Phase 2 study of Fracture of Pelvis (Disorder) that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04249232, a Phase 2 study of Fracture of Pelvis (Disorder), has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a prospective randomized, double-blinded, placebo-controlled, phase 2, three-month study of the efficacy of abaloparatide in postmenopausal women and men ≥ 50 years of age with acute fractures of the pelvis (n=78). The primary outcome is CT image based evidence of fracture healing. The secondary aims are pain and physical performance measures at 3 months. This study will be extended with 9 months of open label abaloparatide to determine if any potential differences between the placebo and abaloparatide groups during the 3 months of treatment are evident and persist over time, even in patients who use abaloparatide after the three-month placebo controlled intervention.
Primary Outcome
Score for cortical bridging on a CT exam at 3 months in abaloparatide versus placebo groups.
Conditions Studied
Interventions
- DRUG Abaloparatide 80 micrograms per Pen dose
- DRUG Placebo prefilled injector pen
Study Locations (3)
New York
- Hospital for Special Surgery - New York
- Mount Sinai - New York
- Westchester Medical Center - Valhalla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-09-17 |
| Est. Completion | 2024-04-25 |
| Phase | Phase 2 |
What the finished NCT04249232 record still lists
NCT04249232 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Fracture of Pelvis (Disorder) appearing as the primary indexed condition, and to 2 interventions - of which Abaloparatide 80 micrograms per Pen dose is the first listed.
NCT04249232 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04249232 about?
NCT04249232 is a clinical study titled "Abaloparatide and Pelvic Fracture Healing". This is a prospective randomized, double-blinded, placebo-controlled, phase 2, three-month study of the efficacy of abaloparatide in postmenopausal women and men ≥ 50 years of age with acute fractures of the pelvis (n=78). The primary outcome is CT image based evidence of fracture healing. The secon...
What is the current status of trial NCT04249232?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2020-09-17. Estimated completion is 2024-04-25.
What conditions does trial NCT04249232 study?
This clinical trial studies the following conditions: Fracture of Pelvis (Disorder).
What interventions are being tested in trial NCT04249232?
The interventions under investigation include: Abaloparatide 80 micrograms per Pen dose (DRUG), Placebo prefilled injector pen (DRUG).
Who is sponsoring clinical trial NCT04249232?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04249232 being conducted?
This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04249232's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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