A DOUBLE-BLIND-STUDY OF INTRANASAL CALCITONIN FOR ESTABLISHED POSTMENOPAUSAL OSTEOPOROSIS

Intranasal administration of calcitonin (CT) avoids the problem of dai ly injections in the long-term treatment of osteoporosis. We examined the effect of nasal CT on bone and calcium metabolism in postmenopausa l osteoporotic women in a double-blind design. 46 women, 55-75 years i n age, and in good general health were included in the study. All pati ents were at least 6 months postmenopausal and had at least 1 vertebra a fracture, bone mineral density (BMD; g/cm(2)) lower than 0.850 in L -2-L-4 in a dual energy x-ray absorptiometry (DEXA) AP view of the spi ne, and showed biochemical indications of a fast bone loser The patien ts were randomly treated with either nasal CT 200 IU per day, divided in 2 doses (n=23) or placebo (n=23) for 1 year. All participants recei ved a daily calcium supplement of 1 g. Clinical and laboratory follow- up every 3 and 6 months, respectively, assessed the clinical picture, bone mineral density measured by DEXA, serum alkaline phosphatase, fas ting urinary calcium, creatinine and hydroxyproline. BMD was measured in 4 sites (spine and cervical, Ward's triangle, and the trochanteric area of the hip) before treatment and after 6 and 12 months of treatme nt. IN the placebo group, mean values at the 4 sites showed a 3.3% dec rease in BMD after 6 months and a 5.0% decrease after 12 months. In co ntrast, the calcitonin group showed a 6.8% increase in BMD after 6 mon ths and 11% increase after 12 months (p less than or equal to 0.005). No patient experienced side-effects and there were no complaints of lo cal irritation. We conclude that nasal administration of 200 IU calcit onin daily, continuously for 1 year had a positive effect on the bone mass density in osteoporotic postmenopausal women.