Effect of rectal salmon calcitonin treatment on bone mass and bone turnover in patients with established postmenopausal osteoporosis: A 1-year crossover study

• Published in: Current therapeutic research Vol. 54; no. 4; pp. 458 - 465
• Main Authors: Gonnelli, Stefano, Agnusdei, Donato, Camporeale, Angelo, Palmieri, Rossella, Gennari, Carlo
• Format: Journal Article
• Language: English
• Published: Belle Mead, NJ EM Inc USA 01.10.1993; Excerpta medica
• Subjects: Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; Medical sciences; Pharmacology. Drug treatments; Human; Salmon calcitonin; Diseases of the osteoarticular system; Peptide hormone; Controlled therapeutic trial; Bone disease; Metabolism; Rectal administration; Osteoporosis; Chemotherapy; Treatment; Placebo; Dosage form; Postmenopause; Female; Bone; Suppository
• DOI: 10.1016/S0011-393X(05)80652-6
• ISSN: 0011-393X

A new suppository formulation of salmon calcitonin (sCT) is now available to increase the choices for the clinician in the treatment of osteoporotic patients. To test this new formulation, we studied the efficacy and tolerability of rectal sCT in 40 patients with postmenopausal osteoporosis. According to a double-blind, placebo-controlled design, the patients were divided into two groups and treated with a daily dose of 100 IU of sCT administered by suppository or matching placebo for 6 months. After 6 months, patients were crossed over so that the sCT-treated group received placebo for the subsequent 6 months and vice versa. Bone mineral density (BMD), measured at the distal radius by dual photon absorptiometry and at the lumbar spine by dual energy X-ray absorptiometry, increased by 3.3% and 3.0%, respectively, after 6 months in the sCt-treated group. The placebo group showed a significant ( P < 0.05) decrease only at the lumbar spine. The differences between the two groups were significant, as determined by one-way analysis of variance. After the crossover period, only the group receiving the active treatment showed an increase in BMD. No significant changes were observed in the biochemical indexes of bone turnover (serum osteocalcin and hydroxyproline/creatinine ratio) in both groups, although during the sCT treatment periods a reduction of bone turnover rate was observed, as demonstrated by the reduction of these markers. This new formulation was well tolerated. Our results indicate that a 6-month treatment with sCT, at a daily dose of 100 IU administered by suppositories, is able to increase bone mass and to exert an inhibitory effect on bone turnover.