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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00384072 |
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Date of registration:
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03/10/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
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Scientific title:
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A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00384072 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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China
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Korea, Republic of
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Taiwan
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For China, medinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Taiwan, medinfo@wyeth.com |
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Key inclusion & exclusion criteria
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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
Age minimum:
45 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Osteoporosis
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Postmenopause
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Intervention(s)
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Drug: bazedoxifene BZA-20
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Primary Outcome(s)
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The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
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Secondary Outcome(s)
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Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
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Serum bone markers at 3 and 6 months
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Lipid profile at 3 and 6 months
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Secondary ID(s)
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3068A1-303
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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