Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol

Exclusion Criteria

• •(1) BMD (L1-4 or T-Hip) T score \< -3.5
• •(2) Have 3 or more vertebral fractures between L1 and L4.
• •(3) Have 1 or more SQ grade 3 vertebral fractures, or 3 or more SQ grade 2 vertebral fractures.
• •(4) Have received a bisphosphonate preparation for 2 weeks or longer within 6 months before the start of study treatment.
• •(5) Have received a bisphosphonate preparation for 2 years or longer within 3 years before the start of study treatment.
• •(6) Have received a parathyroid hormone preparation before the start of study treatment.
• •(7) Have received one or more doses of an anti-RANKL (receptor activator of nuclear factor-kappa B ligand) antibody.
• •(8) Have received one or more doses of an anti-sclerostin antibody or cathepsin K inhibitor.
• •(9) Have received any other investigational product (including placebo) within 16 weeks before the start of study treatment in the present study.
• •(10) Have received any of the following drugs that can affect bone metabolism within 8 weeks before the start of study treatment, with the exception of calcium preparations: (i) Bisphosphonates (ii) Active vitamin D preparations (including those for topical use) (iii) Selective estrogen receptor modulators (SERMs) (iv) Calcitonin preparations (v) Vitamin K2 preparations (vi) Ipriflavone preparations (vii) Reproductive hormone products (except those for vaginal use such as vaginal tablets and creams) (viii) Other drugs that can affect bone metabolism
• •(11) Pregnant woman or woman who desires to become pregnant
• •(12) Have corrected serum calcium \>= 10.4 mg/dL or \< 8.0 mg/dL at enrollment.
• •(13) Have corrected urinary calcium \> 0.4 mg/dL GF at enrollment.
• •(14) Have a past or current history of urinary calculus.
• •(15) Have eGFR \< 30 mL/min/1.73 m2 at enrollment.
• •(16) Have severe liver disease such as cirrhosis or severe heart disease such as severe cardiac failure.
• •(17) Have active malignancy or received treatment for malignancy, including adjuvant therapy, within the past 3 years.
• •(18) Have a history of hypersensitivity to eldecalcitol, alfacalcidol, or other vitamin D preparations.
• •(19) Other persons judged by the investigator (or subinvestigator) to be inappropriate to participate in this study.