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| ID | Type | Description | Link |
|---|---|---|---|
| B2311010 |
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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.
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| Label | Type | Description | Intervention Names |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BZA 20 mg/CE 0.45 mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Mammographic Breast Density at 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. | primary study baseline, Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Women with osteoporosis risk factors who were participants in a phase 3 trial for osteoporosis prevention (study 3115A1-303-WW)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Fort Myers | Florida | 33916 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants who had received bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg, bazedoxifene 20 mg/conjugated estrogen 0.625 mg, raloxifene 60 mg, or placebo in the primary study 3115A1-303 (NCT00675688) for up to 2 years and met the eligibility criteria were eligible to enroll in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| BZA 20 mg/CE 0.625 mg | Drug | 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. |
|
| Raloxifene 60 mg | Drug | 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. |
|
| Placebo | Drug | 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. |
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| Gainesville |
| Florida |
| 32606 |
| United States |
| Pfizer Investigational Site | New Port Richey | Florida | 34652 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Pfizer Investigational Site | Decatur | Georgia | 30033 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60610 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40536-0293 | United States |
| Pfizer Investigational Site | Lousiville | Kentucky | 40291 | United States |
| Pfizer Investigational Site | Southfield | Michigan | 48034 | United States |
| Pfizer Investigational Site | Chaska | Minnesota | 55318 | United States |
| Pfizer Investigational Site | Billings | Montana | 59102 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89146 | United States |
| Pfizer Investigational Site | New Brunswick | New Jersey | 08901 | United States |
| Pfizer Investigational Site | Rochester | New York | 14642 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45267 | United States |
| Pfizer Investigational Site | Wexford | Pennsylvania | 15090 | United States |
| Pfizer Investigational Site | Greenville | South Carolina | 29605 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Charlottesville | Virginia | 22908 | United States |
| Pfizer Investigational Site | Norfolk | Virginia | 23507 | United States |
| Pfizer Investigational Site | São Paulo | RS/Brazil | 01308-050 | Brazil |
| Pfizer Investigational Site | Nijmegen | 1782 GZ | Netherlands |
| Pfizer Investigational Site | Bergen | NO-5094 | Norway |
| Pfizer Investigational Site | Hamar | NO-2317 | Norway |
| FG001 | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. |
| FG002 | Raloxifene 60 mg | Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. |
| FG003 | Placebo | Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. |
| BG001 | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. |
| BG002 | Raloxifene 60 mg | Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. |
| BG003 | Placebo | Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Mammographic Breast Density at 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. | All available participants were analyzed. Here, 'N' (number of participants analyzed) signifies those participants who had technically acceptable mammograms available at primary study baseline and Month 24. | Posted | Mean | Standard Deviation | percent change | primary study baseline, Month 24 |
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This study was not designed to evaluate safety, because safety was evaluated in the primary study 3115A1-303 (NCT00675688). No safety data were collected and reported in this retrospective observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Participants who received bazedoxifene 20 mg/conjugated estrogen 0.45 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. | 0 | 0 | 0 | 0 | ||
| EG001 | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Participants who received bazedoxifene 20 mg/conjugated estrogen 0.625 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. | 0 | 0 | 0 | 0 | ||
| EG002 | Raloxifene 60 mg | Participants who received raloxifene 60 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. | 0 | 0 | 0 | 0 | ||
| EG003 | Placebo | Participants who received placebo capsule orally once daily at approximately the same time each day continuously for 24 months in the primary study 3115A1-303 (NCT00675688), provided mammograms at primary study baseline and Month 24 for digitization and subsequent analysis in this study. | 0 | 0 | 0 | 0 |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020849 | Raloxifene Hydrochloride |
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| 50 to 65 years |
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| Greater than or equal to 65 years |
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| Male |
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