At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,189 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, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Denisty
In Brief
A Phase 3 clinical trial evaluating Alendronate and Denosumab for Osteoporosis and Osteopenia. Completed, enrolled 1,189 participants.
Detailed Summary
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Osteopenia
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2006
First PostedMay 2006
Primary CompletionNov 2007
Study CompletionJan 2008
TodayJul 2026
First PostedMay 26, 2006
Enrollment StartMay 1, 2006
Primary CompletionNov 1, 2007
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.1 years ago
Interventions
Alendronatedrug
ALN; 70 mg; oral; once weekly
Denosumabdrug
60 mg; SC; every 6 months