Calcified Tissue International

, Volume 61, Issue 1, pp 10–15

Equivalence of Nasal Spray and Subcutaneous Formulations of Salmon Calcitonin

  • B.  Combe
  • C.  Cohen
  • F.  Aubin
Article

DOI: 10.1007/s002239900284

Cite this article as:
Combe, B., Cohen, C. & Aubin, F. Calcif Tissue Int (1997) 61: 10. doi:10.1007/s002239900284

Abstract.

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.

Key words: Salmon calcitonin — Nasal spray — Osteoporosis — Vertebral crush fracture. 

Copyright information

© Springer-Verlag New York Inc. 1997

Authors and Affiliations

  • B.  Combe
    • 1
  • C.  Cohen
    • 2
  • F.  Aubin
    • 2
  1. 1.Fédération de Rhumatologie, Hôpital Lapeyronie, 191 avenue du Doyen Gaston Giraud, 34295 Montpellier Cedex 5, FranceFR
  2. 2.Laboratoires Specia, 16 rue Clisson, 75013 Paris, FranceFR

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