Clinical Trial

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta

Study acronym: Cosmic
Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 21 amendments
This ClinicalTrials.gov record has been amended 21 times since 2023-03-03; most recent amendment 2026-02-24.
Status change: Recruiting → Active, Not Recruiting 2024-05-08
Status change: Not Yet Recruiting → Recruiting 2023-05-05
Trial Details
NCT Number NCT05768854
Lead Sponsor Ultragenyx Pharmaceutical Inc
Conditions Osteogenesis Imperfecta
Enrollment 69 participants
Start Date 2023-06-14
Primary Completion 2025-10-23 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-02-25