Study Evaluating Bazedoxifene Acetate in Osteoporosis
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Bazedoxifene Acetate (Drug); Raloxifene (Drug); Placebo (Other)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Summary
The purpose of this study is to determine whether bazedoxifene acetate is safe and effective
in the treatment of osteoporosis in postmenopausal women
Clinical Details
Official title: Fracture Incidence Reduction and Safety of TSE-424 (Bazedoxifene Acetate) Compared to Placebo and Raloxifene in Osteoporotic Postmenopausal Women
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Incidence reduction of new vertebral fractures.To compare the safety profile fo bazedoxifene acetate to placebo.
Secondary outcome: Breast cancer incidence; Clinical vertebral fractures; Worsening vertebral fractures; Nonvertebral fractures; Height changes
Eligibility
Minimum age: 55 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Must be at least 2 years postmenopausal
Exclusion Criteria:
- Diseases that may affect bone metabolism
- Vasomotor symptoms requiring treatment
- Known history or suspected cancer of the breast
Locations and Contacts
Additional Information
Starting date: October 2001
Ending date: September 2010
Last updated: May 6, 2008
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