Trial Outcomes & Findings for Study Evaluating Changes In Mammographic Breast Density (NCT NCT00774267)
NCT ID: NCT00774267
Last Updated: 2014-04-08
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
507 participants
Primary outcome timeframe
primary study baseline, Month 24
Results posted on
2014-04-08
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
132
|
111
|
129
|
135
|
|
Overall Study
COMPLETED
|
132
|
111
|
129
|
135
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Changes In Mammographic Breast Density
Baseline characteristics by cohort
| Measure |
Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg
n=132 Participants
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.
|
Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg
n=111 Participants
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.
|
Raloxifene 60 mg
n=129 Participants
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.
|
Placebo
n=135 Participants
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.
|
Total
n=507 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Less than 50 years
|
20 participants
n=5 Participants
|
19 participants
n=7 Participants
|
14 participants
n=5 Participants
|
24 participants
n=4 Participants
|
77 participants
n=21 Participants
|
|
Age, Customized
50 to 65 years
|
105 participants
n=5 Participants
|
84 participants
n=7 Participants
|
101 participants
n=5 Participants
|
96 participants
n=4 Participants
|
386 participants
n=21 Participants
|
|
Age, Customized
Greater than or equal to 65 years
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
15 participants
n=4 Participants
|
44 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
507 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: primary study baseline, Month 24Population: 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.
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.
Outcome measures
| Measure |
Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg
n=129 Participants
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.
|
Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg
n=105 Participants
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.
|
Raloxifene 60 mg
n=125 Participants
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.
|
Placebo
n=126 Participants
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.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Mammographic Breast Density at Month 24
|
-0.39 percent change
Standard Deviation 1.75
|
-0.05 percent change
Standard Deviation 1.68
|
-0.23 percent change
Standard Deviation 1.76
|
-0.42 percent change
Standard Deviation 1.72
|
Adverse Events
Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Raloxifene 60 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER