Study Evaluating Changes In Mammographic Breast Density

Osteoporosis Clinical Trial

Official title:

Evaluation Of Changes In Mammographic Breast Density Associated With Bazedoxifene Acetate/Conjugated Estrogens, Raloxifene And Placebo In Postmenopausal Women: An Ancillary Study Of Protocol 3115A1-303-WW

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774267
• Other study ID #: 3115A1-4000
• Secondary ID: B2311010
• Status: Completed
• Phase: N/A
• First received: October 16, 2008
• Last updated: March 10, 2014
• Start date: January 2009
• Est. completion date: April 2010

Study information

• Verified date: March 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The objective of the study is to evaluate quantitative changes in mammographic breast density from baseline to 24 months in postmenopausal women receiving daily doses of either BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, Raloxifene or placebo. The primary endpoint in this study is the change in mammographic breast density between baseline and month 24 for each group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 507
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects who have completed all scheduled evaluations in protocol 3115A1-303-WW.

• Completed 24 months of treatment in protocol 3115A1-303.

• Had a mammogram at the baseline visit and at the month 24 visit in protocol 3115A1-303, and both are original films that are technically acceptable for reading.

• Was at least 80% compliant with test article administration during protocol 3115A1-303.

Exclusion Criteria:

• Had a mammogram at either baseline or month 24 during the 3115A1-303 study that was technically unsatisfactory.

• One or both mammograms were digitized when they were obtained during the 3115A1-303 study.

• Had more than one mammogram at either the baseline or month 24 visit of study 3115A1-303.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• BZA 20 mg/CE 0.45 mg
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
• BZA 20 mg/CE 0.625 mg
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
• Raloxifene 60 mg
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as raloxifene tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
• Placebo
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as placebo capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Sao Paulo	RS/Brazil
Netherlands	Pfizer Investigational Site	Nijmegen
Norway	Pfizer Investigational Site	Bergen
Norway	Pfizer Investigational Site	Hamar
United States	Pfizer Investigational Site	Billings	Montana
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Chaska	Minnesota
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Ft. Myers	Florida
United States	Pfizer Investigational Site	Gainesville	Florida
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Lousiville	Kentucky
United States	Pfizer Investigational Site	New Brunswick	New Jersey
United States	Pfizer Investigational Site	New Port Richey	Florida
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Southfield	Michigan
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Wexford	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Brazil,  Netherlands,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Mammographic Breast Density at Month 24	The digitized mammogram pairs were analyzed by a single trained radiologist who determined the density of the breast using software. The only left craniocaudal view was used for assessing breast density.	primary study baseline, Month 24	No

External Links

•   To obtain contact information for a study center near you, click here.