Study Evaluating Changes In Mammographic Breast Density

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: BZA 20 mg/CE 0.45 mg
* Drug: BZA 20 mg/CE 0.625 mg
* Drug: Raloxifene 60 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Drug: BZA 20 mg/CE 0.45 mg<br>* 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.<br>|
| 2<br> | Drug: BZA 20 mg/CE 0.625 mg<br>* 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.<br>|
| 3<br> | Drug: Raloxifene 60 mg<br>* 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.<br>|
| 4<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |