BERLIN — Sept. 14, 1998 — A recently completed study shows that calcitonin-salmon nasal spray reduced by 36 percent the incidence of new spinal fractures in postmenopausal women with osteoporosis.
Dr. Charles Chesnut, professor of radiology and medicine at the University of Washington in Seattle, presented results of the study today at the European Congress on Osteoporosis in Berlin.
Spinal fractures (compressed vertebrae) are the most common complication of osteoporosis. Of the 1.5 million osteoporotic fractures that occur annually in the U.S., 700,000 occur in the spine, according to the National Osteoporosis Foundation.
Spinal fractures result in such irreversible changes as loss of height and stooped posture. However, fractures of the spine and a shrinking frame are not inevitable consequences of aging.
Calcitonin-salmon is currently indicated for treatment of osteoporosis in women who are more than five years past menopause and for whom estrogen replacement therapy is not an option.
More than 1,200 women who had already experienced at least one spinal fracture took part in the five-year trial, called the Prevent Recurrence of Osteoporotic Fractures (PROOF) Study, conducted at 42 sites in the United States and five sites in the United Kingdom. The study was funded by Novartis Pharmaceuticals Corporation, which markets the drug in the U.S. as Miacalcin? Nasal Spray.
Women taking calcitonin-salmon nasal spray (one spray of 200 IUs per day) experienced 36 percent fewer new spinal fractures than those taking placebo. All participants took supplemental calcium and vitamin D. There was no increase in side effects overall compared with women receiving placebo.
“The study results should provide encouragement to the millions of women who have suffered from the debilitating effects of a spinal fracture,” said Chesnut, principal investigator on the study. “The data confirm the ability of a medicine known to be safe to reduce spinal fractures.”
Based on the study results, Novartis filed a supplemental new-drug application with the U.S. Food and Drug Administration in July 1998, for use of calcitonin-salmon nasal spray for prevention of spinal fractures.
Clinical trials have shown that side effects from calcitonin-salmon are comparable to placebo. Most commonly reported side effects are nasal irritation such as runny nose, crusting and nosebleed, back and/or joint pain, and headache. Because calcitonin is a protein, the possibility of a systemic allergic reaction exists.