At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 504 enrolled
Drug / intervention
alendronate +1 moredrug
Likely dose
alendronate 70 mgfrom 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 Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density
In Brief
A Phase 3 clinical trial evaluating alendronate and Denosumab (AMG 162) for Postmenopausal Osteoporosis. Completed, enrolled 504 participants.
Detailed Summary
The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2006
First PostedSep 2006
Primary CompletionMar 2008
Study CompletionJul 2008
TodayJul 2026
First PostedSep 18, 2006
Enrollment StartSep 1, 2006
Primary CompletionMar 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.8 years ago
Interventions
alendronatedrug
70 mg oral QW
Denosumab (AMG 162)drug
60 mg SC q 6 mos