Study Evaluating Changes In Mammographic Breast Density

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00774267
• Collaborator: (none)
• Enrollment: 507
• Locations: 26
• Duration (Months): 14.9
• Patients Per Site: 19.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: BZA 20 mg/CE 0.45 mg; Drug: BZA 20 mg/CE 0.625 mg; Drug: Raloxifene 60 mg; Drug: Placebo

Study Design

• Study Type: Observational
• Actual Enrollment: 507 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
1	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.
2	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.
3	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.
4	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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Ft. Myers	Florida	United States	33916
2	Pfizer Investigational Site	Gainesville	Florida	United States	32606
3	Pfizer Investigational Site	New Port Richey	Florida	United States	34652
4	Pfizer Investigational Site	West Palm Beach	Florida	United States	33409
5	Pfizer Investigational Site	Decatur	Georgia	United States	30033
6	Pfizer Investigational Site	Chicago	Illinois	United States	60610
7	Pfizer Investigational Site	Lexington	Kentucky	United States	40536-0293
8	Pfizer Investigational Site	Lousiville	Kentucky	United States	40291
9	Pfizer Investigational Site	Southfield	Michigan	United States	48034
10	Pfizer Investigational Site	Chaska	Minnesota	United States	55318
11	Pfizer Investigational Site	Billings	Montana	United States	59102
12	Pfizer Investigational Site	Las Vegas	Nevada	United States	89146
13	Pfizer Investigational Site	New Brunswick	New Jersey	United States	08901
14	Pfizer Investigational Site	Rochester	New York	United States	14642
15	Pfizer Investigational Site	Raleigh	North Carolina	United States	27609
16	Pfizer Investigational Site	Cincinnati	Ohio	United States	45267
17	Pfizer Investigational Site	Wexford	Pennsylvania	United States	15090
18	Pfizer Investigational Site	Greenville	South Carolina	United States	29605
19	Pfizer Investigational Site	Dallas	Texas	United States	75390
20	Pfizer Investigational Site	San Antonio	Texas	United States	78229
21	Pfizer Investigational Site	Charlottesville	Virginia	United States	22908
22	Pfizer Investigational Site	Norfolk	Virginia	United States	23507
23	Pfizer Investigational Site	Sao Paulo	RS/Brazil	Brazil	01308-050
24	Pfizer Investigational Site	Nijmegen		Netherlands	1782 GZ
25	Pfizer Investigational Site	Bergen		Norway	NO-5094
26	Pfizer Investigational Site	Hamar		Norway	NO-2317

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00774267
• Other Study ID Numbers: 3115A1-4000; B2311010
• First Posted: Oct 17, 2008
• Last Update Posted: Apr 8, 2014
• Last Verified: Mar 1, 2014

• Additional relevant MeSH terms: Osteoporosis; Raloxifene Hydrochloride

Study Results

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.

Arm/Group Title	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg	Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg	Raloxifene 60 mg	Placebo
Arm/Group Description	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.	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.	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.	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.
Period Title: Overall Study
STARTED	132	111	129	135
COMPLETED	132	111	129	135
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg	Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg	Raloxifene 60 mg	Placebo	Total
Arm/Group Description	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.	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.	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.	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 of all reporting groups
Overall Participants	132	111	129	135	507
Age, Customized (participants) [Number]
Less than 50 years	20 15.2%	19 17.1%	14 10.9%	24 17.8%	77 15.2%
50 to 65 years	105 79.5%	84 75.7%	101 78.3%	96 71.1%	386 76.1%
Greater than or equal to 65 years	7 5.3%	8 7.2%	14 10.9%	15 11.1%	44 8.7%
Sex: Female, Male (Count of Participants)
Female	132 100%	111 100%	129 100%	135 100%	507 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Mammographic Breast Density at Month 24
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg	Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg	Raloxifene 60 mg	Placebo
Arm/Group Description	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.	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.	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.	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.
Measure Participants	129	105	125	126
Mean (Standard Deviation) [percent change]	-0.39 (1.75)	-0.05 (1.68)	-0.23 (1.76)	-0.42 (1.72)

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg		Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg		Raloxifene 60 mg		Placebo
Arm/Group Description	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.		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.		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.		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.
All Cause Mortality
	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg		Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg		Raloxifene 60 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg		Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg		Raloxifene 60 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg		Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg		Raloxifene 60 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.