Osteoporosis
Conditions
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.
Interventions
DRUGBZA 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.
DRUGBZA 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.
DRUGRaloxifene 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.
DRUGPlacebo
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.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil, Netherlands, Norway, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 132 |
| 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. | 111 |
| 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. | 129 |
| 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. | 135 |
| Total | 507 |
Baseline characteristics
| Characteristic | Total | Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Raloxifene 60 mg | Placebo |
|---|---|---|---|---|---|
| Age, Customized 50 to 65 years | 386 participants | 105 participants | 84 participants | 101 participants | 96 participants |
| Age, Customized Greater than or equal to 65 years | 44 participants | 7 participants | 8 participants | 14 participants | 15 participants |
| Age, Customized Less than 50 years | 77 participants | 20 participants | 19 participants | 14 participants | 24 participants |
| Sex: Female, Male Female | 507 Participants | 132 Participants | 111 Participants | 129 Participants | 135 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: primary study baseline, Month 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg | Percent Change From Baseline in Mammographic Breast Density at Month 24 | -0.39 percent change | Standard Deviation 1.75 |
| Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg | Percent Change From Baseline in Mammographic Breast Density at Month 24 | -0.05 percent change | Standard Deviation 1.68 |
| Raloxifene 60 mg | Percent Change From Baseline in Mammographic Breast Density at Month 24 | -0.23 percent change | Standard Deviation 1.76 |
| Placebo | Percent Change From Baseline in Mammographic Breast Density at Month 24 | -0.42 percent change | Standard Deviation 1.72 |