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Abstract
A subanalysis of results from a randomized, double-blind, placebo-controlled, parallel-group,
2-year study was conducted to evaluate the response of individual patients to therapy
with 200 IU/d calcitonin salmon nasal spray compared with placebo in postmenopausal
women who had low bone mass. All patients received 500 mg/d of oral supplemental calcium.
A response to therapy was defined as an increase from baseline in lumbar vertebral
bone mineral density, measured by use of dual-energy x-ray absorptiometry, at the
end of 2 years of treatment. Of 41 valid completers (ie, patients who met the entry
criteria, were compliant with the protocol, and completed the study) treated with
calcitonin salmon nasal spray, 31 (76%) responded positively to treatment. Of 40 valid
completers who received placebo, 25 (63%) lost bone mass (P = 0.001 between groups). The relative risk of bone loss for patients receiving calcitonin
salmon nasal spray was 0.19 (95% confidence interval, 0.07 to 0.50), representing
an 81% risk reduction. This subanalysis demonstrates that the benefits of calcitonin
salmon nasal spray therapy were seen in the majority of women studied. Calcitonin
salmon nasal spray represents an effective therapeutic alternative for osteoporotic
women more than 5 years postmenopause who reject or cannot tolerate estrogens or for
whom estrogens are contraindicated.
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© 1995 Published by Elsevier Inc.