Study Finds Osteoporosis Drug Prevents Additional Fractures in the Spine

Embargoed: Thursday, September 11, 1997 at 7:00 am

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Ryan Peal or Karen Cohen, Fleishman-Hillard, (212) 265-9150

STUDY FINDS OSTEOPOROSIS DRUG PREVENTS ADDITIONAL FRACTURES IN THE SPINE

National Osteoporosis Foundation Comments on New Osteoporosis Study

Cincinnati, OH September 11, 1997: Women with established osteoporosis who have already experienced a vertebral fracture may be able to reduce their risk of additional fractures in the spine by taking calcitonin-salmon, a currently available medication delivered via nasal spray, according to a new study presented this week at the annual scientific meeting of the American Society for Bone and Mineral Research (ASBMR). In commenting on this study, the National Osteoporosis Foundation (NOF) said that the findings are especially important since multiple vertebral fractures lead to the loss of height and stooped posture that is commonly associated with osteoporosis. "Many women are not aware that the loss of height and stooped posture associated with osteoporosis is actually the result of fractures of the spinal bones," points out Sandra C. Raymond, executive director of the National Osteoporosis Foundation. "If we can prevent multiple fractures from occurring in the spine, we can help women avoid the irreversible changes that happen as the spine collapses. Fractures and a shrinking frame are not inevitable consequences of aging, a fact underscored by the results of this study," emphasizes Ms. Raymond.

The PROOF (Prevent Recurrence of Osteoporotic Fractures) study was designed to evaluate more than 1,000 women at 42 U.S. centers to determine whether calcitonin-salmon nasal spray reduces the risk of new and/or worsening fractures in postmenopausal women with established osteoporosis. The study results showed that postmenopausal women taking the presently prescribed dose of 200 mg. of calcitonin were as much as 37 percent less likely to develop new vertebral fractures. "Preventing fractures is the important outcome when treating osteoporosis," explains Charles H. Chesnut III, M.D., F.A.C.P., professor of medicine and director of the Osteoporosis Research Group at the University of Washington Medical Center, and one of the lead study investigators. "Women who are battling this disease should be encouraged because the reduction in fracture rates with calcitonin-salmon nasal spray were significant. After three years, 12 percent of women taking the drug had a new vertebral fracture, as opposed to nearly 20 percent in the placebo group."

Vertebral Fractures Lead to Long-Term Changes Forty percent of all women will have at least one spinal fracture by the time they reach age 80, according to the National Osteoporosis Foundation. Spinal fractures, which are also called vertebral fractures, can cause the spine to begin collapsing over time, leading to pain, a loss of height and stooped posture. Experts agree that it is critical to treat or try to prevent osteoporosis in the early stages of the disease because osteoporosis often leads to multiple vertebral fractures that will permanently change the strength and shape of the spine.

Currently, the drug therapy regimens for osteoporosis include estrogen and bisphosphonates. The therapy evaluated in the PROOF study presented at the American Society for Bone and Mineral Research scientific meeting was calcitonin-salmon nasal spray. Calcitonin-salmon nasal spray is a synthetic formulation of a naturally occurring hormone that inhibits bone removal. In women who are at least five years beyond menopause, calcitonin has been shown to slow bone loss, increase spinal bone density, and, according to anecdotal reports, relieve the pain associated with bone fractures. Calcitonin is available as an injection or nasal spray. Osteoporosis is a major public health threat for more than 28 million Americans, 80 percent of whom are women. In the U.S. today, 10 million individuals already have the disease and 18 million more may have low bone mass, putting them at increased risk for osteoporosis. According to the National Osteoporosis Foundation, osteoporosis is responsible for 1.5 million fractures annually, including 700,000 vertebral fractures, more than 300,000 hip fractures and hundreds of thousands of fractures at other bone sites, and is characterized by inadequate bone formation, deterioration of bones due to excessive bone loss or a combination of both. The National Osteoporosis Foundation is the only non-profit, voluntary health organization devoted to the prevention, diagnosis and treatment of osteoporosis. With more than 170,000 members and donors nationwide, NOFís mission is to eradicate the disease through research, education, legislation and advocacy.

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