N/A
N=507
Study Evaluating Changes In Mammographic Breast Density
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00774267 ↗Enrolled (actual)
507
Serious AEs
—
Results posted
Dec 2013
Primary outcome: Primary: Percent Change From Baseline in Mammographic Breast Density at Month 24 — -0.39; -0.05; -0.23; -0.42 percent change
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- BZA 20 mg/CE 0.45 mg (Drug); BZA 20 mg/CE 0.625 mg (Drug); Raloxifene 60 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Mammographic Breast Density at Month 24 |
-0.39; -0.05; -0.23; -0.42 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00774267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.