Toshitsugu Sugimoto1, Masataka Shiraki2, Tetsuo Nakano3, Hideaki Kishimoto4, Masako Ito5, Masao Fukunaga6, Teruki Sone7, Hiroshi Hagino8, Takami Miki9, Yoshiki Nishizawa10, Shinobu Akachi11, Toshitaka Nakamura12. 1. a Internal Medicine 1 , Shimane University Faculty of Medicine , Shimane , Japan. 2. b Research Institute and Practice for Involutional Diseases , Nagano , Japan. 3. c Tamana Central Hospital , Kumamoto , Japan. 4. d Nojima Hospital , Tottori , Japan. 5. e Center for Diversity and Inclusion, Nagasaki University , Nagasaki , Japan. 6. f Kawasaki Medical School , Okayama , Japan. 7. g Department of Nuclear Medicine, Kawasaki Medical School , Okayama , Japan. 8. h School of Health Science , Tottori University , Tottori , Japan. 9. i Izumiotsu Municipal Hospital , Osaka , Japan. 10. j Inoue Hospital , Osaka , Japan. 11. k Asahi Kasei Pharma Corporation , Tokyo , Japan. 12. l Japan Osteoporosis Foundation , Tokyo , Japan.
Abstract
OBJECTIVE: Very few reports have described changes in bone mineral density (BMD) with long-term, once weekly administration of elcatonin, and its effects in reducing incident fractures remain unverified. Therefore, the efficacy and safety of once weekly elcatonin were examined over a 3 year period. METHODS: This was a multicenter, double-blinded, randomized, placebo-controlled study. Postmenopausal women with primary osteoporosis received either 20 units of elcatonin (EL group, n = 433) or placebo (P group, n = 436) once a week for 144 weeks (3 years) intramuscularly. The primary endpoint was the incidence of new vertebral fractures at 24, 48, 72, 96, 120, and 144 weeks after the start. Secondary endpoints were the incidence of non-vertebral fractures, changes in lumbar, hip total and femoral neck BMD, and the incidence of adverse drug reactions (ADRs). RESULTS: No significant reduction in the incidence of new vertebral fractures was found in the EL group. The percentage increase in lumbar BMD was significantly higher in the EL group from 24 weeks to the last administration. Although the EL group showed tendencies toward smaller decreased hip total and femoral neck BMD, no significant differences were observed between groups. The incidence of ADRs was significantly greater in the EL group, although these have all been previously reported and no new safety concerns were identified. CONCLUSIONS: Once weekly injection of 20 units of elcatonin significantly increased lumbar BMD over a 3 year period and did not cause any safety problems, but no significant reduction in the incidence of vertebral or non-vertebral fractures was demonstrated.
RCT Entities:
OBJECTIVE: Very few reports have described changes in bone mineral density (BMD) with long-term, once weekly administration of elcatonin, and its effects in reducing incident fractures remain unverified. Therefore, the efficacy and safety of once weekly elcatonin were examined over a 3 year period. METHODS: This was a multicenter, double-blinded, randomized, placebo-controlled study. Postmenopausal women with primary osteoporosis received either 20 units of elcatonin (EL group, n = 433) or placebo (P group, n = 436) once a week for 144 weeks (3 years) intramuscularly. The primary endpoint was the incidence of new vertebral fractures at 24, 48, 72, 96, 120, and 144 weeks after the start. Secondary endpoints were the incidence of non-vertebral fractures, changes in lumbar, hip total and femoral neck BMD, and the incidence of adverse drug reactions (ADRs). RESULTS: No significant reduction in the incidence of new vertebral fractures was found in the EL group. The percentage increase in lumbar BMD was significantly higher in the EL group from 24 weeks to the last administration. Although the EL group showed tendencies toward smaller decreased hip total and femoral neck BMD, no significant differences were observed between groups. The incidence of ADRs was significantly greater in the EL group, although these have all been previously reported and no new safety concerns were identified. CONCLUSIONS: Once weekly injection of 20 units of elcatonin significantly increased lumbar BMD over a 3 year period and did not cause any safety problems, but no significant reduction in the incidence of vertebral or non-vertebral fractures was demonstrated.
Entities:
Keywords:
Elcatonin; bone mineral density; fracture; once weekly injection; osteoporosis