Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal Asian women.

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

Details

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

Criteria

Inclusion Criteria:

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

2. Subjects must qualify for one of the following categories (a or b):

1. Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors

2. Equal or greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (values of -1 and -2.5 are acceptable) with at least one osteoporosis risk factor

Exclusion Criteria:

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

2. BMD T-score at the lumbar spine or femoral neck less than -2.5

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