drugset / Trial / NCT02352753

Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI

NCT02352753

Phase 3 Terminated 153 enrolled Amgen
NaSequentialOpen-labelTreatment

Summary

This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.

Timeline

Start
2015-06-24
Primary completion
2022-03-26
Completion
2022-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 1 mg/kg Subcutaneous