Study Evaluating Changes In Mammographic Breast Density

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

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 Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: 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
• Enrollment (Actual): 507

Contacts and Locations

Study Locations

• Brazil
  • RS/Brazil
    • Sao Paulo, RS/Brazil, Brazil, 01308-050
      • Pfizer Investigational Site
• Netherlands
  • Nijmegen, Netherlands, 1782 GZ
    • Pfizer Investigational Site
• Norway
  • Bergen, Norway, NO-5094
    • Pfizer Investigational Site
  • Hamar, Norway, NO-2317
    • Pfizer Investigational Site
• United States
  • Florida
    • Ft. Myers, Florida, United States, 33916
      • Pfizer Investigational Site
    • Gainesville, Florida, United States, 32606
      • Pfizer Investigational Site
    • New Port Richey, Florida, United States, 34652
      • Pfizer Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • Pfizer Investigational Site
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Pfizer Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Pfizer Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0293
      • Pfizer Investigational Site
    • Lousiville, Kentucky, United States, 40291
      • Pfizer Investigational Site
  • Michigan
    • Southfield, Michigan, United States, 48034
      • Pfizer Investigational Site
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • Pfizer Investigational Site
  • Montana
    • Billings, Montana, United States, 59102
      • Pfizer Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Pfizer Investigational Site
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Pfizer Investigational Site
  • New York
    • Rochester, New York, United States, 14642
      • Pfizer Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Pfizer Investigational Site
  • Pennsylvania
    • Wexford, Pennsylvania, United States, 15090
      • Pfizer Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75390
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Pfizer Investigational Site
    • Norfolk, Virginia, United States, 23507
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: October 16, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (Estimate): October 17, 2008

Study Record Updates

• Last Update Posted (Estimate): April 8, 2014
• Last Update Submitted That Met QC Criteria: March 10, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Raloxifene Hydrochloride
• Other Study ID Numbers: 3115A1-4000; B2311010