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Sponsored by: |
Wyeth |
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00205777 |
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women
Condition | Intervention | Phase |
Osteoporosis |
Drug: Bazedoxifene Acetate Drug: Raloxifene Other: Placebo |
Phase III |
MedlinePlus related topics: | Fractures Osteoporosis |
ChemIDplus related topics: | Raloxifene Raloxifene hydrochloride Bazedoxifene Bazedoxifene Acetate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Fracture Incidence Reduction and Safety of TSE-424 (Bazedoxifene Acetate) Compared to Placebo and Raloxifene in Osteoporotic Postmenopausal Women |
Estimated Enrollment: | 7609 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Active Comparator |
Drug: Bazedoxifene Acetate
BZA 20mg BZA 40mg
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B: Active Comparator |
Drug: Bazedoxifene Acetate
BZA 20mg BZA 40mg
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C: Active Comparator |
Drug: Raloxifene
60mg
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D: Placebo Comparator |
Other: Placebo
Placebo
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Ages Eligible for Study: | 55 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3068A1-301 |
First Received: | September 16, 2005 |
Last Updated: | May 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00205777 |
Health Authority: | United States: Food and Drug Administration |
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