Long-term tolerability of nasal spray formulation of salmon calcitonin

One hundred postmenopausal women with osteoporosis treated with nasal spray calcitonin were followed up in three centers for 15 months. The therapeutic regimen consisted of four cycles of continuous treatment, each followed by a one-month drug-free interval. At any study visit, no more than three patients showed abnormal finding at rhinoscopy. Only four patients did not complete the study due to adverse events, all of moderate intensity. As far as the analgesic effect of study drug is concerned, for all variables, a statistically significant improvement (P < 0.01) was observed between baseline conditions and subsequent evaluations. Analgesic consumption also decreased significantly during the study. No statistically significant changes in either bone mineral density or bone mineral content were observed during 15 months of observation. The results of this study confirm that nasal spray calcitonin is well tolerated and does not cause pathological abnormalities at the site of administration as indicated by repeated rhinoscopy examinations.