TY - JOUR
T1 - Eldecalcitol is superior to alfacalcidol in maintaining bone mineral density in glucocorticoid-induced osteoporosis patients (e-GLORIA)
AU - Matsumoto, Toshio
AU - Yamamoto, Kazuhiko
AU - Takeuchi, Tsutomu
AU - Tanaka, Yoshiya
AU - Tanaka, Sakae
AU - Nakano, Tetsuo
AU - Ito, Masako
AU - Tomomitsu, Tatsushi
AU - Hirakawa, Akihiro
AU - Soen, Satoshi
N1 - Funding Information:
This study was supported by a fund from Chugai Pharmaceutical Co. Ltd.
Funding Information:
T.M. has received consulting fees from Chugai, Amgen Astellas Biopharma, Teijin Pharma, Daiichi-Sankyo and Asahi Kasei Pharma. K.Y. has received speaking fees, and/or honoraria from AbbVie, Astellas, AYUMI Pharma, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Mitsubishi-Tanabe, Ono and UCB Japan. T.T. has received grants from Astellas, Chugai, Daiichi-Sankyo, Takeda, AbbVie, Asahi Kasei Pharma, Mitsubishi-Tanabe, Pfizer, Eisai, AYUMI Pharma, Nipponkayaku, Novartis and Shionogi. Honoraria from Astellas, AbbVie, AYUMI Pharma, Eisai., Gilead Sciences, GlaxoSmithKline, Sanofi., Taiho, Mitsubishi-Tanabe, Diaichi-Sankyo, Chugai, Taisho Pharma, Eli Lilly Japan, Novartis, Boehringer-Ingelheim, Nipponkayaku, Pfizer, Bristol–Myers Squibb, Janssen and UCB Japan. Y.T. has received speaker fee and/or honoraria from Daiichi-Sankyo, Astellas, Chugai, Eli Lilly Japan, Pfizer, AbbVie, YL Biologics, Bristol-Myers Squibb, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Teijin Pharma, and has received research grants from Asahi Kasei Pharma, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers Squibb, UCB Japan, Daiichi-Sankyo, Eisai and Ono. S.T. has received consulting fees, speaker fees, and/or honoraria from Amgen Astellas Biopharma, Astellas, Asahi Kasei Pharma, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly Japan, Ono, Pfizer, Taisho Toyama Pharma and Teijin Pharma. M.I. has received consulting fees, speaker fees, honoraria, and/or research funding from Chugai, Astellas, Asahi Kasei Pharma, Daiichi-Sankyo, Eli Lilly Japan, MSD, Ono and Pfizer. A.H. has received consulting fees, speaker fees, honoraria, and/or research funding from Astellas, Ono and Teijin Pharma. S.S. has received consulting fees, speaker fees, and/or honoraria from Asahi Kasei Pharma, Astellas, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly Japan, MSD, Ono, Pfizer, Takeda and Teijin Pharma. Other authors reported no conflict of interest related to this work.
Publisher Copyright:
© 2020, The Japanese Society Bone and Mineral Research and Springer Japan KK, part of Springer Nature.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/7/1
Y1 - 2020/7/1
N2 - Introduction: Eldecalcitol increases bone mineral density (BMD) and reduces vertebral fracture in patients with primary osteoporosis. However, the effect of eldecalcitol on BMD and fracture in glucocorticoid-induced osteoporosis (GIO) patients is unknown. This study was undertaken to compare the effect of eldecalcitol on BMD and fracture with that of alfacalcidol in GIO patients. Materials and methods: A randomized, open-label, parallel group study was conducted to identify the effectiveness and safety of monotherapy with 0.75 μg eldecalcitol compared with 1.0 μg alfacalcidol in GIO patients. Results: Lumbar spine BMD increased with eldecalcitol, but decreased with alfacalcidol at 12 and 24 months (between group difference 1.29%, p < 0.01, and 1.10%, p < 0.05, respectively). Total hip and femoral neck BMD were maintained until 24 months by eldecalcitol, but decreased by alfacalcidol (between group difference 0.97%, p < 0.05 and 1.22%, p < 0.05, respectively). Both bone formation and resorption markers were more strongly suppressed by eldecalcitol than by alfacalcidol. Eldecalcitol showed better effect on BMD than alfacalcidol in patients with no prevalent fracture and BMD > 70% of the young adult mean, and with ≤ 3 months of previous glucocorticoid treatment. No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups. Conclusions: Eldecalcitol was more effective than alfacalcidol in maintaining BMD in GIO patients. Because eldecalcitol was effective in patients with no or short-term previous glucocorticoid treatment, as well as those without prevalent fracture or low BMD, eldecalcitol can be a good candidate for primary prevention of GIO. Clinical trial registration number: UMIN000011700.
AB - Introduction: Eldecalcitol increases bone mineral density (BMD) and reduces vertebral fracture in patients with primary osteoporosis. However, the effect of eldecalcitol on BMD and fracture in glucocorticoid-induced osteoporosis (GIO) patients is unknown. This study was undertaken to compare the effect of eldecalcitol on BMD and fracture with that of alfacalcidol in GIO patients. Materials and methods: A randomized, open-label, parallel group study was conducted to identify the effectiveness and safety of monotherapy with 0.75 μg eldecalcitol compared with 1.0 μg alfacalcidol in GIO patients. Results: Lumbar spine BMD increased with eldecalcitol, but decreased with alfacalcidol at 12 and 24 months (between group difference 1.29%, p < 0.01, and 1.10%, p < 0.05, respectively). Total hip and femoral neck BMD were maintained until 24 months by eldecalcitol, but decreased by alfacalcidol (between group difference 0.97%, p < 0.05 and 1.22%, p < 0.05, respectively). Both bone formation and resorption markers were more strongly suppressed by eldecalcitol than by alfacalcidol. Eldecalcitol showed better effect on BMD than alfacalcidol in patients with no prevalent fracture and BMD > 70% of the young adult mean, and with ≤ 3 months of previous glucocorticoid treatment. No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups. Conclusions: Eldecalcitol was more effective than alfacalcidol in maintaining BMD in GIO patients. Because eldecalcitol was effective in patients with no or short-term previous glucocorticoid treatment, as well as those without prevalent fracture or low BMD, eldecalcitol can be a good candidate for primary prevention of GIO. Clinical trial registration number: UMIN000011700.
KW - Active vitamin D
KW - Alfacalcidol
KW - Fracture
KW - Secondary osteoporosis
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U2 - 10.1007/s00774-020-01091-4
DO - 10.1007/s00774-020-01091-4
M3 - Article
C2 - 32140784
AN - SCOPUS:85081031651
VL - 38
SP - 522
EP - 532
JO - Journal of Bone and Mineral Metabolism
JF - Journal of Bone and Mineral Metabolism
SN - 0914-8779
IS - 4
ER -