Eldecalcitol is superior to alfacalcidol in maintaining bone mineral density in glucocorticoid-induced osteoporosis patients (e-GLORIA).
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.
['Matsumoto|Toshio|T|', 'Yamamoto|Kazuhiko|K|', 'Takeuchi|Tsutomu|T|', 'Tanaka|Yoshiya|Y|', 'Tanaka|Sakae|S|', 'Nakano|Tetsuo|T|', 'Ito|Masako|M|', 'Tomomitsu|Tatsushi|T|', 'Hirakawa|Akihiro|A|', 'Soen|Satoshi|S|']
D015415:Biomarkers D015519:Bone Density D050071:Bone Density Conservation Agents D016723:Bone Remodeling D005260:Female D005272:Femur Neck D005938:Glucocorticoids D006615:Hip D006801:Humans D006887:Hydroxycholecalciferols D053208:Kaplan-Meier Estimate D008159:Lumbar Vertebrae D008297:Male D008875:Middle Aged D010024:Osteoporosis D016103:Spinal Fractures D014807:Vitamin D
Alfacalcidol Fracture Active vitamin D Secondary osteoporosis