Osteoporosis Clinical Trial
Official title:
A Multicenter, Double Blind, Randomized, Placebo and Raloxifene Controlled Study to Assess Safety and Efficacy of TSE-424 (Bazedoxifene Acetate) in the Prevention of Postmenopausal Osteoporosis
The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.
Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene
acetate), an investigational drug, in comparison with those of placebo and raloxifene in
preventing osteoporosis in postmenopausal women.
Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an
investigational drug, in comparison with that of placebo and raloxifene on endometrium,
metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will
be collected for population pharmacokinetic (PK) analysis.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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