Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
Evaluation of Changes in Mammographic Breast Density Associated With Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW
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.
研究概览
地位
条件
研究类型
注册
联系人和位置
学习地点
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Vejle、丹麦、DK-7100
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Sofia、保加利亚、1431
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Sofia、保加利亚、1303
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Zadar、克罗地亚、23000
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Zagreb、克罗地亚、10000
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British Columbia
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Vancouver、British Columbia、加拿大、V5Z 2N6
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Manitoba
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Winnipeg、Manitoba、加拿大、R3A 1M3
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Quebec
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Quebec City、Quebec、加拿大、G1V 3M7
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Sherbrooke、Quebec、加拿大、J1H 4J6
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Johannesburg、南非、2196
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Parow、南非、7500
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Pretoria、南非
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Somerset West、南非、7130
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Agarismo、墨西哥、11800
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Goiania、巴西、74175-080
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Mato Grosso、巴西、78008-400
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Sao Paulo
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Sorocaba、Sao Paulo、巴西、18095-458
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Santiago、智利
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Krakow、波兰、30510
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Warszawa、波兰、02-341
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Tallin、爱沙尼亚、101 28
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Tartu、爱沙尼亚、50410
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Bucharest、罗马尼亚、70231
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Cluj-Napoca、罗马尼亚、3400
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Iasi, Jud. Iasi、罗马尼亚、6600
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California
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San Diego、California、美国、92108
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Upland、California、美国、91786
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Idaho
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Meridian、Idaho、美国、83642
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Minnesota
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Brooklyn Center、Minnesota、美国、55430
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Montana
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Billings、Montana、美国、59101
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Bozeman、Montana、美国、59715
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North Dakota
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Bismark、North Dakota、美国、58503
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Fargo、North Dakota、美国、58104
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Jamestown、North Dakota、美国、58401
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South Dakota
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Watertown、South Dakota、美国、57201
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Amsterdam、荷兰、1081 HV
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Buenos Aires、阿根廷
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
- Each subject must have participated or is currently participating in study 3068A1 301, and must satisfy all of the following criteria
- Has completed 24 months of treatment.
- Had a mammogram at the baseline visit and at the month 24 visit, and both are original films that are technically acceptable for reading.
- Was less than or equal to 62 years of age at the time of study randomization in the primary study.
- Was at least 80% compliant with test article administration.
- Did not take any medications 6 months prior to screening in the primary study or during the first 24 months of the study that could cause a change in breast density.
- Was enrolled at a site that has at least 4 subjects meeting all of the above inclusion criteria.
- Was enrolled at a clinical site that is still participating in the primary study.
学习计划
研究是如何设计的?
设计细节
合作者和调查者
调查人员
- 首席研究员:Trial Manager、For Poland, WPWZMED@wyeth.com
- 首席研究员:Trial Manager、For Romania, WVPIMED@wyeth.com
- 首席研究员:Trial Manager、For South Africa, ZAFinfo@wyeth.com
- 首席研究员:Trial Manager、For Brazil, xavierl@wyeth.com
- 首席研究员:Trial Manager、For Mexico, gomezzlj@wyeth.com
- 首席研究员:Trial Manager、For Canada, clintrialparticipation@wyeth.com
- 首席研究员:Trial Manager、For Croatia, WPBUMED@wyeth.com
- 首席研究员:Trial Manager、For Argentina, Scheima@wyeth.com
- 首席研究员:Trial Manager、For Chile, scheima@wyeth.com
- 首席研究员:Trial Manager、For Denmark, medinfonord@wyeth.com
- 首席研究员:Trial Manager、For Estonia, WVPMED@wyeth.com
- 首席研究员:Trial Manager、For Bulgaria, WVPIMED@wyeth.com
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 3068A1-400
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.