抄録
A multi-center double-blind study was carried out on the effect of TZ-CT, synthetic salmon calcitonin (S) on lumbago due to postmenopausal and senile osteoporosis using elcatonin (E) as the reference drug on 294 patients. Following results were obtained.
1. There was no significant difference in global improvement rating between S and E groups. Efficacy rate was 63.2% in S and 65.0% in E group.
2. There was no significant difference in overall safety between the groups. Safety rate was 95.7% in S and 95.6% in E group.
3. Smaller number of cases were judged useless according to the global utility rating in S than in E group. However, no significant difference in the global utility rating was noted between the groups. The global utility rate was 61.5% in S and 68.0% in group.
4. There was no significant difference in the incidence of side effects between the two groups, 4.4% in S and 4.7% in E group. Administration had to be discontinued due to side effects in a smaller number of cases in S than E group.
5. Serious abnormalities occurred in the labolatory data in neither of the two groups.
In conclusion, S was found to be favorably compared with E in the treatment for osteoporosis as to the efficacy and safety. Utility of S in the treatment of postmenopausal and senile osteoporosis was thus established.