Study Evaluating Changes In Mammographic Breast Density

Pfizer507 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

507

Conditions

Osteoporosis

Interventions

BZA 20 mg/CE 0.45 mgDRUG

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 mgDRUG

Raloxifene 60 mgDRUG

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.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (26)

Pfizer Investigational Site

Outcomes

Primary Outcomes

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.

Time frame: primary study baseline, Month 24

Data from ClinicalTrials.gov

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