EQUIVALENCE OF NASAL SPRAY AND SUBCUTANEOUS FORMULATIONS OF SALMON-CALCITONIN

The aim of this study was to assess the efficacy and safety of nasal s pray and subcutaneous formulations of salmon calcitonin. Two-hundred-f our patients, 27 males and 177 females, aged 72 years on average, with a recent, painful, vertebral crush fracture were given either 50 IU/d ay of subcutaneous salmon calcitonin (SCSCT, 102 patients) or 200 IU/d ay of intranasal salmon calcitonin (LNSCT, 102 patients) for 30 consec utive days, according to a doubleblind, double-placebo design. The two -sided 95% confidence interval of the difference between the two formu lations for the pain on D30 assessed by Huskisson's Visual Analogue Sc ale (VAS) [-5.3 mm, 7.9 mm] was included in the [-10 mm, 10 mm] refere nce interval. Equivalence of the two formulations, was demonstrated. A t the end of the study, the 95% confidence intervals of VAS of both tr eatment groups were included in the [0 mm, 30 mm] interval, which is c onsidered to be clinically pertinent. Relief was obtained in less than 10 days for more than 50% of patients. The urinary hydroxyproline/cre atinine and calcium/creatinine ratios remained constant between DI and D30 with both formulations. General safety was comparable between the two formulations. Local safety of INSCT was similar to that of its pl acebo.