drugset / Trial / NCT05972551

Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

NCT05972551

Phase 3 Active not recruiting 111 enrolled Amgen
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.

Timeline

Start
2024-04-22
Primary completion
2027-05-04
Completion
2027-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Romosozumab Monoclonal antibody Subcutaneous