At a glance
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Abaloparatide Versus Placebo for Pelvic Fracture Healing - A Phase 2 Randomized Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Abaloparatide 80 micrograms per Pen dose and Placebo prefilled injector pen for Fracture of Pelvis (Disorder). Completed, enrolled 48 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
prefilled injector pen to deliver 80 micrograms daily subcutaneously
prefilled injector pen to deliver inactive solution daily subcutaneously