- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00384072
Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
December 19, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100730
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Beijing, China, 100700
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Nanjing, China, 210008
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Shanghai, China, 200040
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Shanghai, China, 200011
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Shanghai, China, 100730
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Tianjin, China, 300052
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Tianjin, China, 300211
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Tianjin, China, 200233
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 133-792
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Suwon, Korea, Republic of, 443-721
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Kaohsuing, Taiwan, 833
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Kaoshsuing, Taiwan, 807
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Tainan, Taiwan, 704
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Taipei, Taiwan, 100
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Tapei, Taiwan, 105
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal
Subjects must qualify for one of the following categories (a or b):
- Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors
- 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:
- One (1) or more osteoporotic vertebral fractures (T4 - L4)
- BMD T-score at the lumbar spine or femoral neck less than -2.5
- Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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 Measures
Outcome Measure |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
October 3, 2006
First Submitted That Met QC Criteria
October 3, 2006
First Posted (Estimate)
October 4, 2006
Study Record Updates
Last Update Posted (Estimate)
December 28, 2007
Last Update Submitted That Met QC Criteria
December 19, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Osteoporosis
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Bone Density Conservation Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Bazedoxifene
Other Study ID Numbers
- 3068A1-303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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