At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 135 enrolled
Drug / intervention
denosumab +2 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 With a Six Month Open-Label Extension to Evaluate the Efficacy and Safety of Denosumab in Korean Postmenopausal Women With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating denosumab, placebo, and 1 other intervention for Osteoporosis, Postmenopausal. Completed, enrolled 135 participants across 10 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 Korean postmenopausal women with osteoporosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Postmenopausal
CountriesSouth Korea
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartNov 2011
Primary CompletionDec 2012
Study CompletionJun 2013
TodayJul 2026
First PostedOct 24, 2011
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2012
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.7 years ago
Interventions
denosumabdrug
double-blind phase: 60mg subcutaneous injection, single dose
placebodrug
double-blind phase: placebo subcutaneous injection, single dose
open-label denosumabdrug
open-label phase: 60mg subcutaneous injection, single dose