Study Evaluating Changes In Mammographic Breast Density

Completed

• Conditions: Osteoporosis
• Interventions: Drug: BZA 20 mg/CE 0.45 mg; Drug: BZA 20 mg/CE 0.625 mg; Drug: Placebo; Drug: Raloxifene 60 mg

• Registration Number: NCT00774267
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Study Start: 2009-01
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2013-10-30
• Results First Submitted QC: 2013-10-30
• Results First Posted: 2013-12-20
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-10
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 507

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	BZA 20 mg/CE 0.45 mg	-
2	BZA 20 mg/CE 0.625 mg	-
4	Placebo	-
3	Raloxifene 60 mg	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Mammographic Breast Density at Month 24	primary study baseline, 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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇳🇴 Hamar, Norway