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Study Evaluating Changes In Mammographic Breast Density

Last updated on April 11, 2018

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Study Location
Pfizer Investigational Site
Ft. Myers, Florida, 33916 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00774267
Pfizer
Completed
Study Evaluating Changes In Mammographic Breast Density

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Study Evaluating Changes In Mammographic Breast Density
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample
Women with osteoporosis risk factors who were participants in a phase 3 trial for osteoporosis prevention (study 3115A1-303-WW)
Osteoporosis
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
507
April 2010
April 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
40 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Netherlands,   Norway,   United States
 
 
NCT00774267
3115A1-4000
B2311010
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

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