JPRN-UMIN000011700已完成未知
Eldecalcitol for GLucocorticoid induced OsteopoRosIs versus Alfacalcidol - e-GLORIA trial Eldecalcitol for GLucocorticoid induced OsteopoRosIs versus Alfacalcidol
e-GLORIA trial Protocol Review Committee (Executive Committee)0 个研究点目标入组 373 人开始时间: 2013年9月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 373
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 85years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(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.
研究者
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