Study Evaluating Changes In Mammographi… | Clinical Trial

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Pfizer Investigational Site, São Paulo, RS/Brazil, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BZA 20 mg/CE 0.45 mg

Drug

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

Drug

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

Drug

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

Drug

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.

Primary outcomes

Percent Change From Baseline in Mammographic Breast Density at Month 24

Time frame: primary study baseline, 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Oct 17, 2008
Registry last updated: Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed