Calcitonin-Salmon Nasal Spray Reduces Incidence Of Spinal Fractures In Women With Osteoporosis

A recently completed study of more than 1,200 postmenopausal women with osteoporosis has concluded that calcitonin-salmon nasal spray reduces by 36 percent the incidence of new spinal fractures. The Prevent Recurrence of Osteoporotic Fractures (PROOF) Study, conducted at 42 sites in the U.S. and five sites in the UK, was funded by Novartis Pharmaceuticals, which markets the drug in the U.S. as Miacalcin Nasal Spray.

The results of the study were presented by Dr. Charles Chesnut, professor of radiology and medicine at the University of Washington, at the European Congress on Osteoporosis in Berlin.

Spinal fractures (compressed vertebrae) are the most common complication of osteoporosis, resulting in such irreversible changes as loss of height and stooped posture. 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.

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.

All participants in the trial took supplemental calcium and Vitamin D. Women taking calcitonin-salmon nasal spray (one spray of 200 IUs per day) experienced 36 percent fewer new spinal fractures than those taking placebo. There was no increase in side effects overall compared with women receiving placebo.

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.

For more information: Laurie McHale, University of Washington. Telephone: 206-543-3620.