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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Osteoporosis; Postmenopause

Treatments: Drug: bazedoxifene BZA-20

Study type: Interventional

Funder types: Industry

Identifiers

NCT00384072

3068A1-303

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind