Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Bazedoxifene; Raloxifene Hydrochloride

Criteria

Inclusion Criteria:

• Generally healthy women 45 years of age or older who are at least 1 year postmenopausal.

• Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.

Exclusion Criteria:

• One (1) or more osteoporotic vertebral fractures (T4-L4).

• Diseases that may affect bone metabolism.

• Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.