drugset / Trial / NCT02632916
Denosumab for the Treatment of Osteoporosis in Children: A Pilot Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Denosumab | Monoclonal antibody | 1 mg/kg | Subcutaneous |
| Comparator | Zoledronic acid | Other / unclassified | 0.025 mg/kg | Intravenous |