OsteoporosisNCT00774267
Study Evaluating Changes In Mammographic Breast Density
An observational study of Osteoporosis, run by Pfizer at 26 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg and Raloxifene 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 507 participants
- Where
- 26 sitesin 4 countries
- Study dates
- Jan 2009to Apr 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with osteoporosis risk factors who were participants in a phase 3 trial for osteoporosis prevention (study 3115A1-303-WW)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
United States22 sites
Pfizer Investigational Site
Billings, Montana, 59102
Pfizer Investigational Site
Charlottesville, Virginia, 22908
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Cincinnati, Ohio, 45267
Pfizer Investigational Site
Dallas, Texas, 75390
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Fort Myers, Florida, 33916
Pfizer Investigational Site
Gainesville, Florida, 32606
Pfizer Investigational Site
Greenville, South Carolina, 29605
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Lexington, Kentucky, 40536-0293
Pfizer Investigational Site
Lousiville, Kentucky, 40291
Pfizer Investigational Site
New Brunswick, New Jersey, 08901
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
Norfolk, Virginia, 23507
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Southfield, Michigan, 48034
Pfizer Investigational Site
West Palm Beach, Florida, 33409
Pfizer Investigational Site
Wexford, Pennsylvania, 15090
Norway2 sites
Pfizer Investigational Site
Bergen, NO-5094
Pfizer Investigational Site
Hamar, NO-2317
About this study
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
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.
- Conditions
- Osteoporosis
- Being tested
- BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, Raloxifene 60 mg, Placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BZA 20 mg/CE 0.45 mgDrug
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.
BZA 20 mg/CE 0.625 mgDrug
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 mgDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: BZA 20 mg/CE 0.45 mg | |
| 2 | Not described Receives: Drug: BZA 20 mg/CE 0.625 mg | |
| 3 | Not described Receives: Drug: Raloxifene 60 mg | |
| 4 | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: primary study baseline, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774267
- Sponsor's protocol ID
- 3115A1-4000
- Other IDs
- B2311010
- Status last verified
- Mar 2014
- First submitted
- 16 Oct 2008
- Last updated
- 8 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00774267
- Acronym / sponsor ID
- 3115A1-4000
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Posted 20 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: BZA 20 mg/CE 0.45 mg |
| 2 | – | Drug: BZA 20 mg/CE 0.625 mg |
| 3 | – | Drug: Raloxifene 60 mg |
| 4 | – | Drug: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with osteoporosis risk factors who were participants in a phase 3 trial for osteoporosis prevention (study 3115A1-303-WW)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BZA 20 mg/CE 0.45 mgThere 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 | 1 |
| BZA 20 mg/CE 0.625 mgThere 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 | 2 |
| Raloxifene 60 mgThere 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 | 3 |
| PlaceboThere 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. | Drug | 4 |
Primary outcome
Percent Change From Baseline in Mammographic Breast Density at Month 24
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Pfizer at 26 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Norway, Brazil, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Mammographic Breast Density at Month 24 (time frame: primary study baseline, Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.