At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Romosozumabdrug
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.
An Open-label, Randomized Study to Estimate the Percent Change From Baseline in Lumbar Spine Bone Mineral Density After 3 Months of AMG 785 Administration in Postmenopausal Women With Low Bone Mineral Density Previously Treated With Alendronate
In Brief
A Phase 1 clinical trial evaluating Romosozumab for Osteoporosis. Completed, enrolled 60 participants across 9 sites.
Detailed Summary
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
First PostedMay 2012
Primary CompletionNov 2012
TodayJul 2026
First PostedMay 1, 2012
Enrollment StartMar 30, 2012
Primary CompletionNov 21, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.2 years ago
Interventions
Romosozumabdrug
Administered by subcutaneous injection