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| |  Non-Hormonal Approach Will Help Women Prevent Bone Loss TORONTO, ON -- October 28, 1997 -- Fosamax® (alendronate sodium), a bone-building treatment for women with osteoporosis has been approved by the Health Protection Branch (HPB) of Health Canada for the prevention of osteoporosis. Fosamax is now the first and only non-hormonal option for osteoporosis prevention. This means Canadian women at risk of developing osteoporosis now have access to a non-hormonal preventative treatment. “Several non-pharmacological approaches can be taken by women to prevent the onset of osteoporosis. But for many, these measures are not enough and a pharmacological treatment is required,” said Dr. Christine Derzko, head of the reproductive endocrinology and infertility division of the department of obstetrics and gynecology at St. Michael’s Hospital in Toronto. “Up until today, our only option was hormone replacement therapy. With the introduction of Fosamax 5mg, we now have access to a non-hormonal safeguard.” An estimated 2.2 million women in Canada are at risk for osteoporosis due to low bone mass or other risk factors such as early menopause or heredity. Clinical data indicates women in the 45 to 60-year-old group not receiving preventive therapy experience a rapid decline in bone mass in the early years following menopause Ð particularly in the first three to six years. This loss in bone mass may lead to the development of osteoporosis and to an increased risk of fracture. Additionally, 40 per cent of women entering menopause today will experience at least one osteoporotic fracture during their remaining lifetime. The approval of Fosamax 5mg is based on an extensive, randomized, double-blind, placebo-controlled, two-year study of women between the age of 45 and 59. In this large clinical trial of 1,609 postmenopausal women, 86.1 per cent of patients on Fosamax 5mg gained bone mass density at the spine, hip and total body. In comparison, women in the placebo group experienced a significant loss in bone mineral density Ð moving them closer to osteoporosis and their fracture threshold.
“If appropriate actions are not taken immediately, the incidence of osteoporotic fractures will increase two- to three-fold as the population ages,” Dr. Derzko said. “The approval of Fosamax 5mg represents an important milestone in the prevention of osteoporosis. The medical community now has a powerful non-hormonal option to prevent the serious and painful consequences of osteoporosis.”
In addition to its disease prevention role, Fosamax has been simultaneously approved to prevent osteoporotic fractures in women. This finding is critical for women with osteoporosis. Preventing osteoporotic fractures, especially the first fracture, is pivotal to minimizing the long-term debilitating effects of the disease.
Fosamax 5mg is taken once daily. It is generally well-tolerated with side effects comparable to placebo. As with any other drugs, Fosamax should be taken according to dosing instructions. Fosamax works by inhibiting bone resorption resulting in a net increase in bone mass. It is the first of a class of drugs called amino-bisphosphonates.
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