Bazedoxifene Causes No Increase in Breast Density: Presented at NAMS

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Title: Bazedoxifene Causes No Increase in Breast Density: Presented at NAMS
URL: http://www.pslgroup.com/dg/22DEB2.htm
Doctor's Guide
September 30, 2008

By Deborah Brauser

ORLANDO, Fla -- September 30, 2008 -- Bazedoxifene, a selective oestrogen receptor module, does not cause an increase in breast density among postmenopausal women with osteoporosis, according to findings presented at the North American Menopause Society (NAMS) 19th Annual Meeting.

Jennifer Harvey, MD, University of Virginia, Charlottesville, Virginia, reported the results of a retrospective analysis of 2-year data from a phase 3 trial here on September 26.

"These types of studies are important," said Dr. Harvey. "Some people might say that overall, decreases in breast density percentages are so small as to be insignificant. But many of these women don't have a lot of density to lose. So we want to be very careful in our evaluations."

Increased mammographic breast density has been associated with an increased risk of breast cancer, in addition to making the interpretation of mammograms more difficult. Therefore, Dr. Harvey and colleagues conducted their study to evaluate the effects of bazedoxifene on breast density compared with raloxifene and placebo after 24 months of treatment.

The original 3-year, multicentre study was an evaluation of the effects of daily bazedoxifene 20 or 40 mg, raloxifene 60 mg, or placebo on fracture reduction among 26,000 postmenopausal women aged 55 to 85 years with osteoporosis. The women were given mammograms at baseline and at 24 months. Original mammographic film pairs for each subject were digitised at a central imaging centre, masked, and sent for evaluation to a single radiologist, who was blinded to the time sequence of the images, treatment assignment, and all subject information.

For their ancillary retrospective analysis, Dr. Harvey and colleagues re-examined the mammograms of those women in the original study who were aged 62 years or younger and had completed at least 24 months of treatment. Of the 726 subjects meeting the criteria, the researchers obtained mammogram pairs from 444 subjects (mammograms from 2 subjects were excluded after they were determined to be too light for accurate evaluation). Breast density was measured using interactive thresholding to segment the mammogram, and percentage breast density was determined using a previously validated software program.

Results of this analysis showed that the median changes in breast density were similar among all treatment groups, with no significant increases in breast density after 24 months of therapy.

"I would have liked even more mammograms to evaluate," said Dr. Harvey. "But overall, we were glad to see that the changes in breast density with bazedoxifene were so similar to the others."

Funding for this trial was provided by Wyeth Research.

[Presentation tile: The Effects of Bazedoxifene on Mammographic Breast Density in Postmenopausal Women With Osteoporosis. Abstract S-6]

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