The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women.
- Must be at least 2 years postmenopausal
- Osteoporotic subjects without vertebral fracture who meet BMD criteria, or
Osteoporotic subjects with vertebral fracture
- Diseases that may affect bone metabolism
- Vasomotor symptoms requiring treatment
- Known history or suspected cancer of the breast
- Active or past history of venous thromboembolic events
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women | |||
| Official Title ICMJE | Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women | |||
| Brief Summary | The purpose of this study is to determine whether bazedoxifene acetate is safe and effective in the treatment of osteoporosis in postmenopausal women. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
| Condition ICMJE | Osteoporosis | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Christiansen C, Chesnut CH 3rd, Adachi JD, Brown JP, Fernandes CE, Kung AW, Palacios S, Levine AB, Chines AA, Constantine GD. Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis. BMC Musculoskelet Disord. 2010 Jun 22;11:130. doi: 10.1186/1471-2474-11-130. | |||
| * 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 | |||
| Actual Enrollment ICMJE | 7609 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | September 2010 | |||
| Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 55 Years to 80 Years (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 | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00205777 | |||
| Other Study ID Numbers ICMJE | 3068A1-301 B1781001 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | February 2013 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
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
