Phase 3Active, not recruiting
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta (Cosmic)
An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta Types I, III or IV
- Sponsor
- Ultragenyx Pharmaceutical Inc (Industry)
- Enrollment
- 69 enrolled
- Conditions
- Osteogenesis Imperfecta
- Interventions
- Bisphosphonate; Setrusumab
- Ages
- children
- Registry
- NCT05768854, CTIS2023-504196-24-00
Full record on ClinicalTrials.gov
From the registry
The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.
Primary outcomes
- Annualized Rate of All Radiographically-Confirmed Fractures, Including Morphometric Vertebral Fractures, at the Primary Analysis
History
Study completion expected
Last registry update
Primary completion
Started
Registered