Clinical trial NCT00774267: Study Evaluating Changes In Mammographic Breast Density
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 507
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percent Change From Baseline in Mammographic Breast Density at Month 24
timeFrame: primary study baseline, Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Ft. Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lousiville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Southfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Chaska
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Wexford
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: RS/Brazil
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Hamar
country: Norway
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: