[Salmon calcitonin nasal spray in the treatment of Paget's disease].

Salmon calcitonin (sCT) is biologically effective when intranasally (i.n.) administered. CT is the treatment of choice for Paget's disease; however, the chronic nature of the disease makes parenteral administration uncomfortable due to the high incidence of adverse reactions occurring after CT injection. The aim of our study was to investigate the efficacy, safety and tolerability of a sCT i.n. spray in the long-term treatment of Paget's disease. Ten pts (4M,6F; age between 58-74 years) with radiological lesions characteristic of Paget's disease, serum alkaline phosphatase (sALP) levels at least 50% above the normal range and never treated for their disease before, were given 200 IU/day of sCT nasal spray for 6 months. sALP levels were measured at month 3 and 6 of therapy; clinical data were recorded every month. sALP levels significantly dropped after 3 months of treatment (72 +/- 6% of basal level, p less than 0.01). After 6 months of therapy sALP levels were similar to the 3 month levels. Pain and functional impairment self-evaluated by the patients decreased after 6 months of therapy: pain index from 5.5 +/- 2.2 to 2.1 +/- 1.1, p less than 0.01; functional impairment index from 2.2 +/- 0.5 to 0.7 +/- 0.5, p less than 0.01. Side-effects were not observed during the entire period of the study. In conclusion, the 200 IU daily regimen of the i.n. spray of sCT without absorption enhancer was, for our patients, effective, safe, and well tolerated in the long-term therapy of Paget's disease.