Study Evaluating Changes In Mammographic Breast Density - Full Text View

Purpose

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.

Condition	Intervention
Osteoporosis	Drug: BZA 20 mg/CE 0.45 mg Drug: BZA 20 mg/CE 0.625 mg Drug: Raloxifene 60 mg Drug: Placebo

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Raloxifene hydrochloride

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:

The primary endpoint for this study is the change in mammographic breast density between baseline and month 24 for each treatment group. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment:	497
Study Start Date:	January 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	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.
2	Drug: 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.
3	Drug: 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.
4	Drug: 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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women with osteoporosis risk factors who were participants in a phase 3 trial for osteoporosis prevention (study 3115A1-303-WW)

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774267

Show 26 Study Locations

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00774267 History of Changes
Other Study ID Numbers:	3115A1-4000, B2311010
Study First Received:	October 16, 2008
Last Updated:	April 7, 2011
Health Authority:	Brazil: National Committee of Ethics in Research United States: Institutional Review Board

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Estrogens, Conjugated (USP)
Raloxifene
Estrogens
Hormones

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 16, 2013