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| |  Canada Approves Miacalcin NS Nasal Spray For Osteoporosis TORONTO, ON and MONTREAL, QC -- February 10, 2000 -- Canadian women may feel the benefits of a new and effective osteoporosis treatment in their bones. Health Canada has approved Miacalcin NS, the first nasal spray treatment for osteoporotic women, at least five years into their menopause. Miacalcin nasal spray (synthetic calcitonin-salmon) from Novartis offers a significant four fold-advantage: it is very effective in reducing fractures, is easy to administer, has no food and no observed drug interactions and, because it is taken nasally, spares the osteoporosis patients from potentially serious side-effects seen with some oral medications. "The arrival of Miacalcin NS (nasal spray) is very exciting since about 50 percent of postmenopausal women with osteoporosis refuse, cannot tolerate or should not use estrogen as first-line therapy," said Dr. Aliya Khan, director of the Oakville Bone Centre and associate clinical professor of medicine at McMaster University in Hamilton, Ontario. "And because it is administered nasally, Miacalcin NS is absorbed quickly into the bloodstream. As well, Miacalcin NS has a very favorable safety profile with no contraindications, precautions or restrictions for patients with gastrointestinal, clotting, or kidney disorders, unlike some oral treatments," Dr. Khan added. "Osteoporosis has crippling financial and quality of life consequences on Canadians. Its treatment costs our economy $40 per second and an osteoporosis-related fracture strikes a Canadian every nine minutes," said Suzanne Hebert, president of Osteoporosis Quebec, the province's leading resource for people seeking information on the causes, prevention, detection and treatment of osteoporosis. "Canadian women should consider Miacalcin NS as an important advance in the ongoing battle against osteoporosis." "Final results of the landmark PROOF (Prevent Recurrence of Osteoporotic Fractures) study, involving over 1,200 women over five years, shows that Miacalcin NS reduced the incidence of new spinal fractures in postmenopausal women with osteoporosis by 36 percent," said study author Dr. Charles Chesnut, professor of radiology and medicine at the University of Washington in Seattle. All participants in the study took Miacalcin NS at the recommended daily dose of 200 IUs per day along with supplemental calcium and Vitamin D. "The study results should provide encouragement to the millions of women who have suffered from the debilitating effects of a spinal fracture: data confirms the ability of Miacalcin NS to be safe in reducing spinal fractures, "Dr. Chesnut added. In clinical trials with Miacalcin NS, the overall incidence of side-effects was comparable to placebo. Bone mass revolves around a phenomenon called remodeling. Remodeling consists of breaking down small parts of the bones and reforming them. The breaking down is performed by "osteoclasts" which are large cells within the bone. Nearby bone-forming cells called "osteoblasts" fill the holes left behind. The depletion of estrogen during menopause reduces osteoblast activity, resulting in the escalation of osteoporosis. Although the difference between bone loss and gain is slight over the years, it accounts for a gradual loss of BMD (bone mass density) as a person ages. This almost imperceptible loss has prompted osteoporosis to be referred to as the "Silent Thief." Spinal fractures (compressed vertebrae) are the most common complication of osteoporosis. However, Miacalcin NS inhibits osteoclast activity, thereby reducing bone loss. Among the leading causes of osteoporosis is a great abyss in awareness about the disease that affects about 1 million Canadian women. For example, a 1998 survey of 514 adult American women conducted by Opinion Research International found that only 28 percent knew that women over age 50 were more likely to get osteoporosis than breast cancer, heart disease or Alzheimer's disease. Furthermore, nearly one-half of all women (46 percent) said they know little or nothing about osteoporosis, while 39 percent of women over age 45 never discuss osteoporosis with their doctor -- even though they are at increased risk for the disease. "The message concerning osteoporosis is very clear," Dr. Chesnut said. "Women need to know more about the disease and discuss prevention and treatment possibilities with their physicians. In addition, the message has to be delivered that the addition of versatile drugs like Miacalcin NS offers women with osteoporosis effective and safe treatment options." Related links: Miacalcin, Novartis.
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