[Multicenter comparative study of synthetic salmon calcitonin administered nasally in the treatment of established postmenopausal osteoporosis].

We study the effectivity and tolerance of synthetic salmon calcitonin nasally administered (Miacalcic) in the treatment of established postmenopausic osteoporosis. During one year, two randomized groups of postmenopausic women diagnosed of osteoporosis were treated in an outpatient service either with 1 gr of calcium element per day during the whole study or with 100 daily I.U. of salmon synthetic calcitonin nasally administered in patterns of 14 days and the same period of rest, plus a supplement of 500 mgr of calcium element per day. Globally, 43 patients were assessed at the end of the study in the calcitonin plus calcium group and 45 in the group receiving only calcium. The main evaluation parameters were pain and presence of new fractures. At the beginning and at the end of the study, complementary tests of blood biochemistry were conducted, including alkalin phosphatase, calcium, phosphorus and uric acid, as well as calcium, hydroxiprolin and creatinini in the urine. The results showed a significant improvement of pain (p < 0.001) in the group treated with calcitonin, supported by a lower consumption of analgesics. The rate of vertebral fractures determined according to the Meunier's index, was also significantly lower (p < 0.001) in the group treated with calcitonin at the end of the study period. These results suggest that, compared to only calcium, nasally administered calcitonin precludes the formation of new vertebral fractures during one year of treatment and it is effective in terms of pain reduction.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes