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| |  Canada Approves Fosamax (Alendronate) Plus Hormone Replacement Therapy For Osteoporosis VANCOUVER, BC -- April 17, 2001 -- Fosamax®, the world's leading treatment for osteoporosis can now be used with hormone replacement therapy (HRT) to relieve symptoms of menopause and/or to prevent heart disease. Studies have shown that the combined use of Fosamax (alendronate) + HRT (estrogen +- progestin) results in greater bone mass than seen with either treatment used alone.(1,2) Health Canada granted the inclusion of these findings in the Fosamax product monograph. "This is good news for premenopausal and menopausal women who suffer from osteoporosis," stated Dr. Thirza Smith, President of The Society of Obstetricians and Gynaecologists of Canada. "Now that Fosamax can be used with hormone replacement therapy, it provides an optimal treatment option for these women who will now benefit from what is increasingly being adopted as a therapy of choice in the treatment of osteoporosis," added Dr. Smith. "Although it is known that individually both alendronate and estrogen increase bone mass, they seem to act by different mechanisms and used together lead to greater increases in bone mass," said Dr. Christina Williams, Clinical Assistant Professor, Division of Reproductive Endocrinology & Infertility, University of British Columbia. "And, very importantly, the combination is generally well-tolerated." - In a randomized, two-year study which involved 425 postmenopausal women with low bone mass, women received either placebo, HRT, alendronate or a combination of alendronate + HRT. Those women treated with a combination of alendronate + HRT experienced an average increase in their bone mineral density (BMD) of 8.3 percent compared to an average of 6.0 percent for women who received only alendronate or HRT. Patients receiving placebo experienced an average loss of 0.6 percent BMD.(1) The World Health Organization defines osteoporosis as BMD of less than 2.5 standard deviations below peak adult bone mass. - In a randomized, one-year study, 428 postmenopausal women received the combination of alendronate + HRT or HRT alone. Women who received the combination of alendronate + HRT achieved increases in bone mass at the spine and hip that were two to three percent greater than those observed in women on HRT alone.(2) Osteoporosis affects more than 1.4 million Canadians and one in four women over the age of 50 has osteoporosis. It is characterized by low bone mass, resulting in weak bones that are prone to fracture with little or no pressure, or by the presence of an osteoporotic fracture. During the first five years after menopause, a woman may lose up to a third of the bone she will lose in her lifetime. When a woman loses bone, the structure of her bones may deteriorate, causing them to break easily. Bone mass is closely related to bone strength - the greater the bone mass, the stronger the bones and the less likely they are to fracture. Bone mineral density is considered the most accurate predictor of osteoporotic fracture risk. In Canada, osteoporosis is responsible for more than 25,000 hip fractures which occur each year. Hip, vertebral and wrist fractures are most commonly associated with osteoporosis. Hip fractures alone are estimated to cost the Canadian health care system approximately $400 million per year in acute, long- term and rehabilitative care.
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SOURCE: MERCK FROSST CANADA & CO
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