At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 7,609 enrolled
Drug / intervention
Bazedoxifene Acetate +1 moredrug
Likely dose
Bazedoxifene acetate 20 mg orally dailyAI-extracted
Key inclusion· 2
- ✓At least 2 years postmenopausal
- ✓Osteoporosis diagnosis, either without vertebral fracture meeting BMD criteria OR with vertebral fracture
Key exclusion· 4
- ✕Diseases that may affect bone metabolism
- ✕Vasomotor symptoms requiring treatment
- ✕Known history or suspected breast cancer
- ✕Active or past history of venous thromboembolic events
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women
In Brief
A Phase 3 clinical trial evaluating Bazedoxifene Acetate and Placebo for Osteoporosis. Completed, enrolled 7,609 participants across 375 sites in 30 countries.
Detailed Summary
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Russia, Slovakia, South Africa, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2001
First PostedSep 2005
Primary CompletionSep 2010
TodayJul 2026
First PostedSep 20, 2005
Enrollment StartDec 1, 2001
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 20.8 years ago
Interventions
Bazedoxifene Acetatedrug
BZA 20mg, daily, oral
Placeboother
Placebo, daily, oral