Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
NCT ID: NCT00418236
Last Updated: 2010-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2006-10-31
2010-04-30
Brief Summary
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At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a lack of hormonal stimulation. This is characterized as a decrease in the mammographic density. Although certain medications, including hormone therapy (HT) and dopamine antagonists can increase breast density, these effects are reversible upon discontinuation of the specific agent. Other medications such as the selective estrogen receptor modulators (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM, on breast density are not known. The purpose of this study is to examine the effect of BZA on breast density changes over 24 months in postmenopausal women. The results may be useful for clinicians to understand the effect of BZA on breast density and its mammographic effects.
This is an observational, multicenter, double-blind, randomized, placebo- and active comparator-controlled study. It is also an ancillary that will use women who are already participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo. This ancillary study will request a subset of participants to use their mammograms taken in this study. Their mammogram will be digitized by a central imaging center. A single radiologist will perform the quantifications of breast density from the digitized mammograms.
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Detailed Description
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Conditions
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Study Design
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RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
18 Years
63 Years
FEMALE
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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San Diego, California, United States
Upland, California, United States
Meridian, Idaho, United States
Brooklyn Center, Minnesota, United States
Billings, Montana, United States
Bozeman, Montana, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Jamestown, North Dakota, United States
Watertown, South Dakota, United States
Buenos Aires, , Argentina
Sorocaba, São Paulo, Brazil
Goiânia, , Brazil
Mato Grosso, , Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Santiago, , Chile
Zadar, , Croatia
Zagreb, , Croatia
Vejle, , Denmark
Tallinn, , Estonia
Tartu, , Estonia
Agarismo, , Mexico
Amsterdam, , Netherlands
Krakow, , Poland
Warsaw, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Iasi, Jud. Iasi, , Romania
Johannesburg, , South Africa
Parow, , South Africa
Pretoria, , South Africa
Somerset West, , South Africa
Countries
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Other Identifiers
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3068A1-400
Identifier Type: -
Identifier Source: org_study_id
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