Study Evaluating Changes In Mammographic Breast Density

NCT00774267

Last updated date
Study Location
Pfizer Investigational Site
Ft. Myers, Florida, 33916, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

Contact

[email protected]

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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.

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  23. Seoul, Korea
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0+
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OsteoporosisStudy Evaluating Changes In Mammographic Breast Density NCT00774267
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  2. Gainesville, Florida
  3. New Port Richey, Florida
  4. West Palm Beach, Florida
  5. Decatur, Georgia
  6. Chicago, Illinois
  7. Lexington, Kentucky
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  23. Sao Paulo, RS/Brazil
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years
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  1. Birmingham, Alabama
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Female
55 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
PRS Account Pfizer
Verification Date March 2014