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Trial record 1 of 1 for:    NCT00774267
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Study Evaluating Changes In Mammographic Breast Density

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ClinicalTrials.gov Identifier: NCT00774267
Recruitment Status : Completed
First Posted : October 17, 2008
Results First Posted : December 20, 2013
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date October 16, 2008
First Posted Date October 17, 2008
Results First Submitted Date October 30, 2013
Results First Posted Date December 20, 2013
Last Update Posted Date April 8, 2014
Study Start Date January 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 30, 2013)
Percent Change From Baseline in Mammographic Breast Density at Month 24 [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: October 16, 2008)
The primary endpoint for this study is the change in mammographic breast density between baseline and month 24 for each treatment group. [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: October 16, 2008)
No secondary [ Time Frame: No time frame because there is no secondary ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Osteoporosis
Intervention
  • Drug: BZA 20 mg/CE 0.45 mg
    There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
  • Drug: BZA 20 mg/CE 0.625 mg
    There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
  • Drug: Raloxifene 60 mg
    There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as raloxifene tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
  • Drug: Placebo
    There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as placebo capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
Study Groups/Cohorts
  • 1
    Intervention: Drug: BZA 20 mg/CE 0.45 mg
  • 2
    Intervention: Drug: BZA 20 mg/CE 0.625 mg
  • 3
    Intervention: Drug: Raloxifene 60 mg
  • 4
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 10, 2014)
507
Original Estimated Enrollment
 (submitted: October 16, 2008)
500
Actual Study Completion Date April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil,   Netherlands,   Norway,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00774267
Other Study ID Numbers 3115A1-4000
B2311010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2014