At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 219 enrolled
Drug / intervention
alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus) +2 moredrug
Likely dose
alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus)from 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 6-Month, Randomized, Open-Label, Active-Comparator Controlled, Parallel-Group Study With a 6-Month Extension to Evaluate the Safety and Efficacy of Alendronate Sodium 70 mg/Vitamin D3 5600 I.U. Combination Tablets Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China
In Brief
A Phase 4 clinical trial evaluating alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus), Calcitriol, and 1 other intervention for Osteoporosis, Postmenopausal. Completed, enrolled 219 participants.
Detailed Summary
This study will evaluate whether the once weekly administration of the combination tablet alendronate/vitamin D3 (FOSAMAX PLUS) will increase lumbar spine bone mineral density (BMD) more than the daily use of calcitriol.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Postmenopausal
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2011
Enrollment StartJun 2011
Primary CompletionJan 2013
TodayJul 2026
First PostedMay 10, 2011
Enrollment StartJun 19, 2011
Primary CompletionJan 10, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.1 years ago
Interventions
alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus)drug
one combination tablet once weekly
Calcitrioldrug
0.25 μg once daily orally
Calcium 500 mgdietary
one 500 mg tablet once daily