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Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

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NCT00384072

Last updated on November 9, 2019
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Study Location
Beijing, , 100700 China
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmenopause, Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00384072
Pfizer
Completed
Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

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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 SummaryThe 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 DescriptionNot 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 DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor China, [email protected]
Principal Investigator:Trial ManagerFor Taiwan, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMay 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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