Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
NCT00418236
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Brief Title | Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density | ||||||||||||||||||||||||||||||||||||||||||
Official Title | Evaluation of Changes in Mammographic Breast Density Associated With Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW | ||||||||||||||||||||||||||||||||||||||||||
Brief Summary | It has been shown that women who have dense breasts have an increased risk of breast cancer compared with women whose breasts are less dense. However, while breast density may be a risk factor, the etiology of the relationship between breast cancer and breast density is not understood. Furthermore, it is well recognized that breast cancer can still develop in women whose breasts are not dense. 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. | ||||||||||||||||||||||||||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Study Type | Observational | ||||||||||||||||||||||||||||||||||||||||||
Study Design | Time Perspective: Retrospective | ||||||||||||||||||||||||||||||||||||||||||
Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Biospecimen | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Sampling Method | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Study Population | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Condition | Breast Cancer | ||||||||||||||||||||||||||||||||||||||||||
Intervention | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Study Groups/Cohorts | 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 | Completed | ||||||||||||||||||||||||||||||||||||||||||
Enrollment | 400 | ||||||||||||||||||||||||||||||||||||||||||
Original Enrollment | Same as current | ||||||||||||||||||||||||||||||||||||||||||
Actual Study Completion Date | April 2010 | ||||||||||||||||||||||||||||||||||||||||||
Primary Completion Date | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Eligibility Criteria |
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Sex/Gender |
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Ages | 18 Years to 63 Years (Adult) | ||||||||||||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||||||||
Listed Location Countries | Argentina, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Estonia, Mexico, Netherlands, Poland, Romania, South Africa, United States | ||||||||||||||||||||||||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||||||||||||||
NCT Number | NCT00418236 | ||||||||||||||||||||||||||||||||||||||||||
Other Study ID Numbers | 3068A1-400 | ||||||||||||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Responsible Party | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||||||||||||||
Collaborators | Not Provided | ||||||||||||||||||||||||||||||||||||||||||
Investigators |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||||||||||||||
Verification Date | December 2007 |