At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 24 enrolled
Drug / intervention
Denosumab +1 moredrug
Likely dose
Denosumab 1mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Denosumab and Placebo for Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With and Glucocorticoid-induced Osteoporosis. Completed, enrolled 24 participants across 38 sites in 13 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEvaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With, Glucocorticoid-induced Osteoporosis
CountriesAustralia, Belgium, Bulgaria, Canada, Colombia, India, Italy, Mexico, Peru, Russia, Turkey (Türkiye), Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartMay 2018
Primary CompletionDec 2021
Study CompletionDec 2023
TodayJul 2026
First PostedMay 24, 2017
Enrollment StartMay 7, 2018
Primary CompletionDec 13, 2021
Study CompletionDec 20, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.1 years ago
Interventions
Denosumabdrug
1mg/kg BW (up to a maximum of 60 mg) SC Q6M
Placeboother
SC Q6M placebo