Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density
Public ClinicalTrials.gov record NCT00418236. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of Changes in Mammographic Breast Density Associated With Bazedoxifene, Raloxifene, and Placebo in Postmenopausal Women: An Ancillary Study of Protocol 3068A1-301-WW
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
It has been shown that women who have dense breasts have an increased risk of breast cancer compared with women whose breasts are less dense. However, while breast density may be a risk factor, the etiology of the relationship between breast cancer and breast density is not understood. Furthermore, it is well recognized that breast cancer can still develop in women whose breasts are not dense. At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a lack of hormonal stimulation. This is characterized as a decrease in the mammographic density. Although certain medications, including hormone therapy (HT) and dopamine antagonists can increase breast density, these effects are reversible upon discontinuation of the specific agent. Other medications such as the selective estrogen receptor modulators (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM, on breast density are not known. The purpose of this study is to examine the effect of BZA on breast density changes over 24 months in postmenopausal women. The results may be useful for clinicians to understand the effect of BZA on breast density and its mammographic effects. This is an observational, multicenter, double-blind, randomized, placebo- and active comparator-controlled study. It is also an ancillary that will use women who are already participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo. This ancillary study will request a subset of participants to use their mammograms taken in this study. Their mammogram will be digitized by a central imaging center. A single radiologist will perform the quantifications of breast density from the digitized mammograms.
Study identification
- NCT ID
- NCT00418236
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 63 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2006
- Primary completion
- Not listed
- Completion
- Mar 31, 2010
- Last update posted
- Aug 18, 2010
2006 – 2010
United States locations
- U.S. sites
- 10
- U.S. states
- 6
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | San Diego | California | 92108 | — |
| Not listed | Upland | California | 91786 | — |
| Not listed | Meridian | Idaho | 83642 | — |
| Not listed | Brooklyn Center | Minnesota | 55430 | — |
| Not listed | Billings | Montana | 59101 | — |
| Not listed | Bozeman | Montana | 59715 | — |
| Not listed | Bismarck | North Dakota | 58503 | — |
| Not listed | Fargo | North Dakota | 58104 | — |
| Not listed | Jamestown | North Dakota | 58401 | — |
| Not listed | Watertown | South Dakota | 57201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00418236, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2010 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00418236 live on ClinicalTrials.gov.