EFFECTS OF SALMON-CALCITONIN SUPPOSITORIES ON BONE MASS AND TURNOVER IN ESTABLISHED OSTEOPOROSIS

The objective of this study was to test the efficacy and safety of sal mon calcitonin (sCT) suppository in postmenopausal women with previous hip fractures as an inhibitory agent of bone loss. The study was a si ngle blind, randomized, and placebo-controlled trial comparing three p arallel groups of patients. Fifty-four healthy women were randomly all ocated to 1 year's treatment with either sCT 100 IU/6 times a week, 20 0 IU/3 times a week, or placebo/6 times a week. All groups received a calcium supplement of 500 mg daily. Fifteen patients left the study be fore its end, six of those due to adverse events, such as abdominal an d rectal pain, nausea, headache, and diarrhea. Bone mineral density of the spine and the femoral neck was measured every 26 weeks, and bioch emical markers of bone turnover were measured at baseline and week 12, 26, and 52. There were no significant changes in bone mineral density in the spine and in the hip in any of the treatment groups. No signif icant changes were observed in serum alkaline phosphatase, serum osteo calcin, urine hydroxyproline, and urine pyridinoline or deoxypyridinol ine. Conclusively, we did not observe any significant effect on bone m etabolism in women with postmenopausal osteoporosis after 1 year of tr eatment with sCT suppositories at the doses used.