Trials / Completed
CompletedNCT03164928
Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).
Conditions
- Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With
- Glucocorticoid-induced Osteoporosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Denosumab | 1mg/kg BW (up to a maximum of 60 mg) SC Q6M |
| OTHER | Placebo | SC Q6M placebo |
Timeline
- Start date
- 2018-05-07
- Primary completion
- 2021-12-13
- Completion
- 2023-12-20
- First posted
- 2017-05-24
- Last updated
- 2024-07-19
- Results posted
- 2024-07-19
Locations
38 sites across 13 countries: United States, Australia, Belgium, Bulgaria, Canada, Colombia, India, Italy, Mexico, Peru, Russia, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03164928. Inclusion in this directory is not an endorsement.