Eldecalcitol is superior to alfacalcidol in maintaining bone mineral density in glucocorticoid-induced osteoporosis patients (e-GLORIA).

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  • Additional Information
    • Source:
      Publisher: Japanese Society of Bone and Mineral Metabolism Country of Publication: Japan NLM ID: 9436705 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1435-5604 (Electronic) Linking ISSN: 09148779 NLM ISO Abbreviation: J Bone Miner Metab Subsets: MEDLINE
    • Publication Information:
      Original Publication: Tokyo : Japanese Society of Bone and Mineral Metabolism, [1988-
    • Subject Terms:
      Bone Density*/drug effects; Glucocorticoids/*adverse effects ; Hydroxycholecalciferols/*therapeutic use ; Osteoporosis/*drug therapy ; Osteoporosis/*physiopathology ; Vitamin D/*analogs & derivatives; Biomarkers/metabolism ; Bone Density Conservation Agents/therapeutic use ; Bone Remodeling/drug effects ; Female ; Femur Neck/drug effects ; Femur Neck/physiopathology ; Hip/physiopathology ; Humans ; Hydroxycholecalciferols/adverse effects ; Hydroxycholecalciferols/pharmacology ; Kaplan-Meier Estimate ; Lumbar Vertebrae/drug effects ; Lumbar Vertebrae/physiopathology ; Male ; Middle Aged ; Spinal Fractures/epidemiology ; Vitamin D/adverse effects ; Vitamin D/pharmacology ; Vitamin D/therapeutic use
    • Abstract:
      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.
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    • Contributed Indexing:
      Keywords: Active vitamin D; Alfacalcidol; Fracture; Secondary osteoporosis
    • Accession Number:
      0 (Biomarkers)
      0 (Bone Density Conservation Agents)
      0 (Glucocorticoids)
      0 (Hydroxycholecalciferols)
      1406-16-2 (Vitamin D)
      I2JP8UE90H (eldecalcitol)
      URQ2517572 (alfacalcidol)
    • Publication Date:
      Date Created: 20200307 Date Completed: 20200814 Latest Revision: 20211217
    • Publication Date:
      20240829
    • Accession Number:
      10.1007/s00774-020-01091-4
    • Accession Number:
      32140784