Official Title: “Fracture Incidence Reduction and Safety of TSE-424 (Bazedoxifene Acetate) Compared to Placebo and Raloxifene in Osteoporotic Postmenopausal Women”

The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2010

Intervention(s) in this Clinical Trial

• Drug: Bazedoxifene Acetate
  • BZA 20mg BZA 40mg
• Drug: Raloxifene
  • 60mg
• Other: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B
• Active Comparator: C
• Placebo Comparator: D

Primary Measures

• Incidence reduction of new vertebral fractures.
  • Time Frame: 7 years
    Safety Issue?: No
• To compare the safety profile fo bazedoxifene acetate to placebo.
  • Time Frame: 7 years
    Safety Issue?: No

Secondary Measures

• Breast cancer incidence; Clinical vertebral fractures; Worsening vertebral fractures; Nonvertebral fractures; Height changes
  • Time Frame: 7 years
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00205777

Study ID Number: 3068A1-301

ClinicalTrials.gov Identifier: NCT00205777

Health Authority: United States: Food and Drug Administration