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Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00418236
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : August 19, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date January 2, 2007
First Posted Date January 4, 2007
Last Update Posted Date August 19, 2010
Study Start Date October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00418236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
 (submitted: January 2, 2007)
400
Original Enrollment Same as current
Actual Study Completion Date April 2010
Primary Completion Date Not Provided
Eligibility Criteria
  1. Each subject must have participated or is currently participating in study 3068A1 301, and must satisfy all of the following criteria
  2. Has completed 24 months of treatment.
  3. Had a mammogram at the baseline visit and at the month 24 visit, and both are original films that are technically acceptable for reading.
  4. Was less than or equal to 62 years of age at the time of study randomization in the primary study.
  5. Was at least 80% compliant with test article administration.
  6. 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.
  7. Was enrolled at a site that has at least 4 subjects meeting all of the above inclusion criteria.
  8. Was enrolled at a clinical site that is still participating in the primary study.
Sex/Gender
Sexes Eligible for Study: Female
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Bulgaria, WVPIMED@wyeth.com
Principal Investigator: Trial Manager For Croatia, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For Denmark, medinfonord@wyeth.com
Principal Investigator: Trial Manager For Estonia, WVPMED@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
Principal Investigator: Trial Manager For Romania, WVPIMED@wyeth.com
Principal Investigator: Trial Manager For South Africa, ZAFinfo@wyeth.com
Principal Investigator: Trial Manager For Canada, clintrialparticipation@wyeth.com
Principal Investigator: Trial Manager For Mexico, gomezzlj@wyeth.com
Principal Investigator: Trial Manager For Argentina, Scheima@wyeth.com
Principal Investigator: Trial Manager For Chile, scheima@wyeth.com
Principal Investigator: Trial Manager For Brazil, xavierl@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007