Novel Therapy Significantly Reduces Spinal Fractures In Postmenopausal WomenWith Two Years Of Therapy

er than those of the spine are much less frequent and the spine responds much faster to treatment compared to other bones.

To complement the fracture data, those taking raloxifene were also shown to have a 2 to 3 percent increase in bone density at the hip and spine after 24 months. During the MORE trial, 7705 osteoporatic postmenopausal women (average age 66.5 years old) were randomized to receive either 60 or 120 milligrams per day of raloxifene or a matching dose of placebo. One-third of the women had one or more spinal fractures at baseline; and two-thirds had a low bone mineral density without a spine fracture. The women were recruited from 180 sites in 25 countries.

"These are two-year interim results of the trial and this study will continue for five years to determine the long term effects of raloxifene on women," said Steven Cummings, MD, UCSF professor of medicine and epidemiology and an author of the study. "Raloxifene is a promising drug because previous data presented at the American Society of Clinical Oncology (ASCO) has shown that it reduced the risk of breast cancer by 70 percent in the same group of women."

Raloxifene belongs to a class of drugs called selective estrogen receptor modulators (SERMS), which block the actions of estrogen in some tissues, such as the breasts, and mimic estrogen in other tissues, such as the bones. Raloxifene is similar to other SERMS, such as tamoxifen, because it has a positive, estrogen-like effect on a woman's bones and cholesterol levels. However, raloxifene differs from tamoxifen and estrogen because it does not stimulate the lining of the uterus, Cummings said.

He added that compared to estrogen, raloxifene reduces the risk of breast cancer, and does not cause problems of uterine bleeding and breast tenderness, which may result in women not continuing therapy long term.

According to Cummings, raloxifene has been shown to cause hot flashes in 8 to 10 percent of the women who took the drug, leg cr

Contact: Kathleen Barco
(626) 405-5534
University of California - San Francisco

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