At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 67 enrolled
Drug / intervention
Romosozumab +1 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 Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating Romosozumab and Placebo for Postmenopausal Osteoporosis. Completed, enrolled 67 participants across 10 sites.
Detailed Summary
The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesSouth Korea
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJan 2017
Primary CompletionFeb 2018
Study CompletionDec 2018
TodayJul 2026
First PostedJun 6, 2016
Enrollment StartJan 16, 2017
Primary CompletionFeb 12, 2018
Study CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.1 years ago
Interventions
Romosozumabdrug
Administered by subcutaneous injection once a month (QM)
Placebodrug
Administered by subcutaneous injections once a month