Status:
COMPLETED
Study Evaluating Changes In Mammographic Breast Density
Lead Sponsor:
Pfizer
Conditions:
Osteoporosis
Eligibility:
FEMALE
40-75 years
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, B...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
507 Patients enrolled
Trial Details
Trial ID
NCT00774267
Start Date
January 1 2009
End Date
April 1 2010
Last Update
April 8 2014
Active Locations (26)
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1
Pfizer Investigational Site
Fort Myers, Florida, United States, 33916
2
Pfizer Investigational Site
Gainesville, Florida, United States, 32606
3
Pfizer Investigational Site
New Port Richey, Florida, United States, 34652
4
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33409