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.
