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| |  Benefits Of Fosamax (Alendronate) On Osteoporosis Sustained Over Time Montreal, QC -- August 22, 2000 -- A new research analysis shows that the beneficial effect of Fosamax® (alendronate) the first drug approved in Canada for the treatment and prevention of osteoporosis was evident early on in the treatment and, once achieved, was sustained over time. At as early as one year data from a new analysis of the Fracture Intervention Trial (a three-year, randomized, controlled study conducted among 3,658 women) showed there was a 59 percent reduction in the relative risk for symptomatic spinal fractures among women treated with alendronate compared to placebo. At as early as 18 months, there was a 63 percent difference in relative risk for hip fractures between women treated with alendronate and those who received placebo. Furthermore, researchers found a 27 percent risk reduction (p=0.017) for any symptomatic fracture at 18 months. Whether hip fracture, spine fracture or any symptomatic fracture, the effect of alendronate in fracture reduction was consistent at all time points throughout the three-year analysis. Moreover, once a statistically significant difference from placebo was achieved, it was sustained over the three year response rate. With the increasing aging population among women, osteoporosis has now been recognized as a serious health issue in the last few years contributing to he excessive financial burden on the health care system. For Canadian women who are at risk or already suffer from osteoporosis, the imperative to treat is crucial. "Fortunately Canadian women have more options than ever for the prevention and treatment of osteoporosis," said Dr. Angèle Turcotte, Rheumatologist, the Centre de l'ostéoporose et de rhumatologie de Québec. "In addition to Fosamax there is Miacalin, Evista and now Actonel which was approved in July," added Dr. Turcotte. "In the case of severe osteoporosis, we need fast-acting and well-tolerated therapies like, amongst others, alendronate," explained Dr. Turcotte. "Moreover, with the recent availability of other treatment options many physicians have expressed interest in the long term effects of therapies." More than three million women world-wide have been treated with alendronate and it is approved in more than 80 countries around the world for the treatment of postmenopausal osteoporosis. Alendronate was approved in Canada in December 1995 for the 10 mg indication. The 5 mg tablet form became available in November 1998. "Of the treatments available for the prevention of fractures, Fosamax is the most thoroughly investigated to date," said Dr. Jacques Courville, Vice-President, Medical Research for Merck Frosst Canada & Co. "Despite the fact that there are three other drugs approved, Fosamax is still the most widely prescribed drug for osteoporosis in Canada." Alendronate tolerability has been well studied. A randomized, double-blind, placebo-controlled endoscopy study conducted among 235 postmenopausal women aged 45 to 80 years showed that alendronate is well tolerated even at four times the recommended daily dosage (5 mg to 10 mg). Providing over 24,000 patient years of double-blind, placebo-controlled experience, The Fracture Intervention Trial (FIT) is among the largest and most important studies ever conducted in osteoporosis. The study was originally conducted in two parts. Known as the Vertebral Fracture Study, the first part of FIT focused on women who already had a spine fracture, although many did not know it until they were X-rayed for the study. The other part of FIT, known as the Clinical Fracture Study, studied women who had not suffered a spinal fracture but whose bone density was below normal. Osteoporosis affects more than 1.4 million Canadians. 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. 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 mineraldensity or BMD 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 Cdn$400 million per year in acute, long-term and rehabilitative care. Related Links: Fosamax (alendronate) and Merck Frosst Canada & Co.
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