A randomized, double-blind, placebo-controlled study of once weekly elcatonin in primary postmenopausal osteoporosis
| Autor: | Takami Miki, Masao Fukunaga, Hiroshi Hagino, Shinobu Akachi, Tetsuo Nakano, Masako Ito, Toshitaka Nakamura, Yoshiki Nishizawa, Toshitsugu Sugimoto, Hideaki Kishimoto, Teruki Sone, Masataka Shiraki |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Calcitonin
medicine.medical_specialty Osteoporosis Placebo-controlled study Once weekly 030204 cardiovascular system & hematology Postmenopausal osteoporosis Double blind 03 medical and health sciences 0302 clinical medicine Double-Blind Method Bone Density Elcatonin Internal medicine medicine Humans 030212 general & internal medicine Osteoporosis Postmenopausal Aged Aged 80 and over Bone mineral Lumbar Vertebrae business.industry General Medicine medicine.disease Spinal Fractures Female sense organs business medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 35:447-454 |
| ISSN: | 1473-4877 0300-7995 |
| Popis: | 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.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).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.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. |
| Databáze: | OpenAIRE |
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