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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00205777 |
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Date of registration:
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16/09/2005 |
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Primary sponsor: |
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Public title:
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Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
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Scientific title:
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Fracture Incidence Reduction And Safety Of TSE-424 (Bazedoxifene Acetate) Compared To Placebo And Raloxifene In Osteoporotic Postmenopausal Women |
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Date of first enrolment:
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October 2001 |
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Target sample size:
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7618 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00205777 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Bulgaria
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Canada
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Chile
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Croatia
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Denmark
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Estonia
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Finland
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France
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Germany
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Greece
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Hong Kong
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Hungary
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Italy
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Lithuania
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Mexico
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Netherlands
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New Zealand
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Norway
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Poland
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Romania
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Russian Federation
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Slovakia
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South Africa
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Spain
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must be at least 2 years postmenopausal
- Osteoporotic subjects without vertebral fracture who meet BMD criteria, or
Osteoporotic subjects with vertebral fracture
Exclusion Criteria:
- 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
Age minimum:
55 Years
Age maximum:
80 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Osteoporosis
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Intervention(s)
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Drug: Bazedoxifene Acetate
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Other: Placebo
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Primary Outcome(s)
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Incidence reduction of new vertebral fractures.
[Time Frame: 7 years]
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To compare the safety profile of bazedoxifene acetate to placebo.
[Time Frame: 7 years]
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Secondary Outcome(s)
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Bone mineral density of lumbar spine and hip measured by DXA scans
[Time Frame: 7 years]
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Breast cancer incidence
[Time Frame: 7 years]
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Clinical vertebral fractures assessed by X-rays of spine; number of subjects reporting clinical vertebral fractures; will also report Kaplan Meier rate estimate
[Time Frame: 7 years]
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Height changes in mm from baseline to year seven
[Time Frame: 7 years]
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Lipid parameters
[Time Frame: 7 years]
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Nonvertebral fractures assessed by X-rays of region of interest
[Time Frame: 7 years]
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Serum bone markers blood samples: osteocalcin - marker of bone formation and C-telopeptide (CTX) -marker of bone resorption
[Time Frame: 7 years]
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Worsening vertebral fractures assessed by X-rays of spine
[Time Frame: 7 years]
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Secondary ID(s)
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3068A1-301
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B1781001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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