At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 795 enrolled
Drug / intervention
Denosumab +3 moredrug
Likely dose
Not stated in 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 Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
In Brief
A Phase 3 clinical trial evaluating Denosumab, Placebo for risendronate, and 2 other interventions for Steroid-induced Osteopor, Glucocorticoid-induced Ostepor. Completed, enrolled 795 participants across 99 sites in 16 countries.
Detailed Summary
This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Canada, Colombia, Czechia, Denmark, France, Germany, Hungary, Mexico, Netherlands, Poland, Russia, South Korea, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
First PostedApr 2012
Primary CompletionJun 2016
Study CompletionJun 2017
TodayJul 2026
First PostedApr 12, 2012
Enrollment StartMar 28, 2012
Primary CompletionJun 21, 2016
Study CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.2 years ago
Interventions
Denosumabdrug
Administered by subcutaneous injection once every 6 months
Placebo for risendronatedrug
Administered orally once a day
Risendronatedrug
Administered orally once a day
Placebo for denosumabdrug
Administered by subcutaneous injection once every 6 months