drugset / Trial / NCT05768854

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta

NCT05768854

Phase 3 Active not recruiting 69 enrolled Ultragenyx Pharmaceutical Inc
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-06-14
Primary completion
2025-10-23
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Setrusumab Monoclonal antibody Intravenous