Overview

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