Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418236
Status:
COMPLETED
Last Update Posted:
2010-08-19
First Post:
2007-01-02
Brief Title:
Effect of Bazedoxifene Raloxifene and Placebo on Breast Density
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None