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

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Beijing, , 100700 China
Contact
1-800-718-1021
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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Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Postmenopause
  • Osteoporosis
Drug: bazedoxifene BZA-20
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
September 2007
Not Provided

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
Sexes Eligible for Study: Female
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Korea, Republic of,   Taiwan
 
 
NCT00384072
3068A1-303
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For China, [email protected]
Principal Investigator: Trial Manager For Taiwan, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
May 2007

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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