A randomized, double-blind, placebo-controlled study of once weekly elcatonin in primary postmenopausal osteoporosis.

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.

• Authors: Toshitsugu Sugimoto, Masataka Shiraki, Tetsuo Nakano, Hideaki Kishimoto, Masako Ito, Masao Fukunaga, Teruki Sone, Hiroshi Hagino, Takami Miki, Yoshiki Nishizawa, Shinobu Akachi, Toshitaka Nakamura
• Journal: Current medical research and opinion (Curr Med Res Opin) Vol. 35 Issue 3 Pg. 447-454 (03 2019) ISSN: 1473-4877 [Electronic] England
• PMID: 29986611 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Calcitonin
• elcatonin

Topics

• Aged
• Aged, 80 and over
• Bone Density (drug effects)
• Calcitonin (administration & dosage, analogs & derivatives)
• Double-Blind Method
• Female
• Humans
• Lumbar Vertebrae
• Osteoporosis, Postmenopausal (complications, drug therapy)
• Spinal Fractures (etiology)