At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 250 enrolled
Drug / intervention
denosumab +1 moredrug
Likely dose
denosumab 60mgfrom 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 Six-Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Denosumab in Indian Postmenopausal Women With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating denosumab and placebo for Osteoporosis, Postmenopausal. Completed, enrolled 250 participants across 11 sites.
Detailed Summary
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Indian postmenopausal women with osteoporosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Postmenopausal
CountriesIndia
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartJan 2012
Primary CompletionFeb 2013
TodayJul 2026
First PostedDec 19, 2011
Enrollment StartJan 1, 2012
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.5 years ago
Interventions
denosumabdrug
60mg subcutaneous injection, single dose
placebodrug
placebo subcutaneous injection, single dose