At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 343 enrolled
Drug / intervention
alendronate sodium (+) cholecalciferol +2 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 Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women
In Brief
A Phase 4 clinical trial evaluating alendronate sodium (+) cholecalciferol, Comparator: Alendronate sodium (Fosamax), and 1 other intervention for Osteoporosis Postmenopausal. Completed, enrolled 343 participants.
Detailed Summary
To demonstrate the efficacy/safety of Fosamax Plus D
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis Postmenopausal
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedAug 2008
Primary CompletionApr 2009
TodayJul 2026
First PostedAug 7, 2008
Enrollment StartMar 20, 2008
Primary CompletionApr 10, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.9 years ago
Interventions
alendronate sodium (+) cholecalciferoldrug
Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks
Comparator: Alendronate sodium (Fosamax)drug
Alendronate sodium; tablet, once weekly, for 16 weeks
Comparator: Calciumdietary
500 mg oral tablet calcium once daily, for 16 weeks