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Trial record 1 of 1 for:    NCT00384072
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Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

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ClinicalTrials.gov Identifier: NCT00384072
Recruitment Status : Completed
First Posted : October 4, 2006
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 3, 2006
First Posted Date  ICMJE October 4, 2006
Last Update Posted Date December 28, 2007
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2006)
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
  • Postmenopause
  • Osteoporosis
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
 (submitted: October 3, 2006)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For China, medinfo@wyeth.com
Principal Investigator: Trial Manager For Taiwan, medinfo@wyeth.com
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