Osteoporosis, Postmenopause
Conditions
Keywords
postmenopausal, women, SERM, osteoporosis
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.
Interventions
DRUGbazedoxifene BZA-20
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China, South Korea, Taiwan
Outcome results
None listed