Minodronate combined with alfacalcidol versus alfacalcidol alone for glucocorticoid-induced osteoporosis: a multicenter, randomized, comparative study.

Abstract

INTRODUCTION:

This study compared the clinical usefulness of minodronate (50 mg/4 weeks) plus alfacalcidol (1 μg/day) (Group M) with that of alfacalcidol alone (1 μg/day) (Group A) for treating glucocorticoid-induced osteoporosis.

MATERIALS AND METHODS:

The primary endpoints were the changes from baseline in lumbar spine (LS) bone mineral density (BMD) and the cumulative incidence of vertebral fracture at 24 months; secondary endpoints included the changes from baseline in total hip (TH) BMD and bone turnover markers.

RESULTS:

Of 164 patients enrolled, 152 (Group M, n = 75; Group A, n = 77) were included in the analysis of efficacy. At each time point and at 24 months, LS BMD and TH BMD were significantly higher in Group M than in Group A. The 152 patients were divided into two subgroups that were previously treated with glucocorticoids for ≤ 3 months or > 3 months. In both subgroups, the changes from baseline in LS BMD and TH BMD from baseline at 24 months had increased more in Group M than in Group A. There were no differences found in the incidence of vertebral fracture between the groups, because the number of enrolled patients was lesser than that initially expected. In Group M, both bone formation and resorption markers significantly decreased from baseline at 3 months and maintained at 6, 12, and 24 months.

CONCLUSIONS:

Minodronate plus alfacalcidol was more effective than alfacalcidol alone in increasing BMD and was effective in increasing BMD for both prevention and treatment. Therefore, minodronate can be a good candidate drug for the treatment of glucocorticoid-induced osteoporosis.

• Authors: Satoshi Soen, Kazuhiko Yamamoto, Tsutomu Takeuchi, Yoshiya Tanaka, Sakae Tanaka, Masako Ito, Tetsuo Nakano, Hiroshi Hagino, Akihiro Hirakawa, Toshio Matsumoto
• Journal: Journal of bone and mineral metabolism (J Bone Miner Metab) Vol. 38 Issue 4 Pg. 511-521 (Jul 2020) ISSN: 1435-5604 [Electronic] Japan
• PMID: 31970477 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Biomarkers
• Bone Density Conservation Agents
• Diphosphonates
• Glucocorticoids
• Hydroxycholecalciferols
• Imidazoles
• YM 529
• alfacalcidol

Topics

• Adult
• Aged
• Aged, 80 and over
• Biomarkers (metabolism)
• Bone Density (drug effects)
• Bone Density Conservation Agents (therapeutic use)
• Bone Remodeling (drug effects)
• Diphosphonates (adverse effects, pharmacology, therapeutic use)
• Drug Therapy, Combination
• Female
• Glucocorticoids (adverse effects)
• Humans
• Hydroxycholecalciferols (adverse effects, pharmacology, therapeutic use)
• Imidazoles (adverse effects, pharmacology, therapeutic use)
• Male
• Middle Aged
• Osteoporosis (chemically induced, drug therapy, physiopathology)
• Spinal Fractures (drug therapy, physiopathology)
• Young Adult