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

Phase 3

Completed

• Conditions: Postmenopause; Osteoporosis

• Registration Number: NCT00384072
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-10-03
• Study First Submitted QC: 2006-10-03
• Study First Posted: 2006-10-04
• Status Verified: 2007-05
• Study Completion: 2007-09
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
Serum bone markers at 3 and 6 months
Lipid profile at 3 and 6 months