Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
NCT00384072
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Beijing,
- Beijing,
- Nanjing,
- Shanghai,
- Shanghai,
- Shanghai,
- Tianjin,
- Tianjin,
- Tianjin,
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- Seoul,
- Suwon,
- Kaohsuing,
- Kaoshsuing,
- Tainan,
- Taipei,
- Tapei,
Descriptive Information | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women | |||||||||
Official Title ICMJE | A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women | |||||||||
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. | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 3 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention | |||||||||
Condition ICMJE |
| |||||||||
Intervention ICMJE | Drug: bazedoxifene BZA-20 | |||||||||
Study Arms ICMJE | Not Provided | |||||||||
Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Estimated Enrollment ICMJE | 500 | |||||||||
Original Enrollment ICMJE | Same as current | |||||||||
Actual Study Completion Date ICMJE | September 2007 | |||||||||
Primary Completion Date | Not Provided | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||||||||
Sex/Gender ICMJE |
| |||||||||
Ages ICMJE | 45 Years and older (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | China, Korea, Republic of, Taiwan | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00384072 | |||||||||
Other Study ID Numbers ICMJE | 3068A1-303 | |||||||||
Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||
Responsible Party | Not Provided | |||||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
| |||||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||
Verification Date | May 2007 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |