Equivalence of nasal spray and subcutaneous formulations of salmon calcitonin.
Author(s): Combe B, Cohen C, Aubin F
Affiliation(s): Federation de Rhumatologie, Hopital Lapeyronie, 191 avenue du Doyen Gaston Giraud, 34295 Montpellier Cedex 5, France.
Publication date & source: 1997-07, Calcif Tissue Int., 61(1):10-5.
Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial
The aim of this study was to assess the efficacy and safety of nasal spray and subcutaneous formulations of salmon calcitonin. Two-hundred-four patients, 27 males and 177 females, aged 72 years on average, with a recent, painful, vertebral crush fracture were given either 50 IU/day of subcutaneous salmon calcitonin (SCSCT, 102 patients) or 200 IU/day of intranasal salmon calcitonin (INSCT, 102 patients) for 30 consecutive days, according to a double-blind, double-placebo design. The two-sided 95% confidence interval of the difference between the two formulations for the pain on D30 assessed by Huskisson's Visual Analogue Scale (VAS) [-5.3 mm, 7.9 mm] was included in the [-10 mm, 10 mm] reference interval. Equivalence of the two formulations, was demonstrated. At the end of the study, the 95% confidence intervals of VAS of both treatment groups were included in the [0 mm, 30 mm] interval, which is considered to be clinically pertinent. Relief was obtained in less than 10 days for more than 50% of patients. The urinary hydroxyproline/creatinine and calcium/creatinine ratios remained constant between D1 and D30 with both formulations. General safety was comparable between the two formulations. Local safety of INSCT was similar to that of its placebo.