Study Evaluating Changes In Mammographic Breast Density

Pfizer

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: Placebo; Drug: BZA 20 mg/CE 0.45 mg; Drug: BZA 20 mg/CE 0.625 mg; Drug: Raloxifene 60 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT00774267

B2311010

3115A1-4000

Details and patient eligibility

About

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.

Enrollment: 507 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

507 participants in 4 patient groups

1

Treatment:

Drug: BZA 20 mg/CE 0.45 mg

2

Treatment:

Drug: BZA 20 mg/CE 0.625 mg

3

Treatment:

Drug: Raloxifene 60 mg

4

Treatment:

Drug: Placebo