At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 327 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 Evaluate the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
In Brief
A Phase 3 clinical trial evaluating Romosozumab and Placebo for Osteoporosis. Completed, enrolled 327 participants across 30 sites.
Detailed Summary
The purpose of the study is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in bone mineral density (BMD) at the lumbar spine, at the total hip and femoral neck in postmenopausal Chinese women with osteoporosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedOct 2021
Enrollment StartOct 2021
Primary CompletionNov 2023
TodayJul 2026
First PostedOct 5, 2021
Enrollment StartOct 21, 2021
Primary CompletionNov 9, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 4.7 years ago
Interventions
Romosozumabdrug
Subjects will receive romosozumab in a specified sequence during the treatment Period.
Placebodrug
Subjects will receive Placebo in a specified sequence during the treatment Period.