drugset / Trial / NCT02632916

Denosumab for the Treatment of Osteoporosis in Children: A Pilot Study

NCT02632916

Phase 2 Completed 10 enrolled Children's Hospital of Eastern Ontario
RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of this study is to acquire preliminary, pilot data over a 2-year period on the safety and efficacy of subcutaneous denosumab versus the current CHEO standard-of-care (intravenous zoledronic acid) for the treatment of osteoporosis in children. Both denosumab (1.0mg/kg) and zoledronic acid (0.025mg/kg) will be given as four doses separated by a six month interval (i.e. at baseline, 6 months, 12 months and 18 months), with follow-up to 2 years.

Timeline

Start
2016-08
Primary completion
2020-02-03
Completion
2020-02-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Denosumab Monoclonal antibody 1 mg/kg Subcutaneous
Comparator Zoledronic acid Other / unclassified 0.025 mg/kg Intravenous

Indications