NCT01974167Unknown不适用
Eldecalcitol for GLucocorticoid Induced OsteopoRosIs Versus Alfacalcidol
e-GLORIA trial Protocol Review Committee1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Percent change in lumbar spine (L1-4) bone mineral density
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of eldecalcitol monotherapy compared with alfacalcidol monotherapy in patients with glucocorticoid-induced osteoporosis, using a randomized, open-label, parallel-group, comparative design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients who are currently taking or plan to take oral glucocorticoid medication for 3 months or longer and thus require treatment as per the 'Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and mineral Research (2004),' and who meet at least one of the conditions below. No restriction is imposed on the underlying disease treated with the oral glucocorticoid medication.
- •(i) Have any existing insufficiency fracture (ii) %YAM <80 (iii) Oral glucocorticoid daily dose >= 5 mg prednisolone equivalent
- •(2) Aged between 20 and 85 years (both inclusive) at consent
- •(3) Patients who are able to walk without assistance
- •(4) Provided consent to participate in the study
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 L
- •(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.
研究组 & 干预措施
Eldecalcitol group
Experimental
Eldecalcitol 0.75 microgram once daily orally
干预措施: Eldecalcitol (Drug)
Alfacalcidol group
Active Comparator
Alfacalcidol 1 microgram once daily orally
干预措施: Alfacalcidol (Drug)
结局指标
主要结局
Percent change in lumbar spine (L1-4) bone mineral density
时间窗: 12 months after the start of study drug administration
Incidence of vertebral fractures
时间窗: 36 months
A vertebral fracture will be classified as a new fracture (i.e., change from grade 0 to grade 1, 2, or 3) or worsening of a prevalent fracture (i.e., change from grade 1 to grade 2 or 3, or change from grade 2 to grade 3) using a semi-quantitative \[SQ\] method according to the "Vertebral Fracture Assessment Criteria, 2012 revised version."
次要结局
- Incidence of non-vertebral fractures (both traumatic and non-traumatic; 3 Major sites)(36 months)
- Incidence of non-vertebral fractures (both traumatic and non-traumatic; 6 Major sites)(36 months)
- Incidence of non-vertebral fractures (traumatic; All sites)(36 months)
- Incidence of non-vertebral fractures (traumatic; 3 Major sites)(36 months)
- Incidence of non-vertebral fractures (non-traumatic; 3 Major sites）(36 months)
- Incidence of non-vertebral fractures (non-traumatic; 6 Major sites）(36 months)
- Incidence of non-vertebral fractures (both traumatic and non-traumatic; All sites)(36 months)
- Incidence of vertebral fractures (clinical vertebral fractures)(36 months)
- Incidence of non-vertebral fractures (3 Major sites) by number of prevalent fractures(36 months)
- Incidence of new clinical vertebral fractures by severity(36 months)
- Incidence of FRAX-defined major osteoporotic fractures(36 months)
- Incidence of clinical vertebral fractures by bone mineral density(36 months)
- Incidence of non-vertebral fractures (traumatic; 6 Major sites)(36 months)
- Incidence of non-vertebral fractures (non-traumatic; All sites)(36 months)
- Incidence of vertebral fractures (worsening of prevalent vertebral fractures)(36 months)
- Incidence of vertebral fracture (new or worsening of prevalent fractures) by glucocorticoid dose(36 months)
- Incidence of non-vertebral fractures (3 Major sites) by bone mineral density(36 months)
- Incidence of non-vertebral fractures (6 Major sites) by number of prevalent fractures(36 months)
- Incidence of new non-vertebral fractures (all sites) by severity(36 months)
- Incidence of non-vertebral fractures (all sites) by glucocorticoid dose(36 months)
- Incidence of non-vertebral fractures (3 Major sites) by glucocorticoid dose(36 months)
- Incidence of non-vertebral fractures (6 Major sites) by bone mineral density(36 months)
- Incidence of vertebral fractures (new or worsening) by number of prevalent fractures(36 months)
- Incidence of clinical vertebral fractures by number of prevalent fractures(36 months)
- Incidence of non-vertebral fractures (all sites) by number of prevalent fractures(36 months)
- Incidence of new non-vertebral fractures (6 Major sites) by severity(36 months)
- Incidence of osteoporotic fractures(36 months)
- Change in muscle strength (back muscle strength)(36 months after the start of study drug administration (or at the time of withdrawal from the study))
- Change in muscle strength (grip strength)(36 months after the start of study drug administration (or at the time of withdrawal from the study))
- Change in height(36 months after the start of study drug administration (or at the time of withdrawal from the study))
- Incidence of vertebral fractures (new vertebral fractures)(36 months)
- Incidence of clinical vertebral fractures by glucocorticoid dose(36 months)
- Incidence of non-vertebral fractures (6 Major sites) by glucocorticoid dose(36 months)
- Incidence of non-vertebral fractures (all sites) by bone mineral density(36 months)
- Incidence of new vertebral fractures by severity(36 months)
- Incidence of new non-vertebral fractures (3 Major sites) by severity(36 months)
- Percent change in TRACP-5b bone metabolism marker(12 months after the start of study drug administration)
- Incidence of vertebral fractures (new or worsening) by bone mineral density(36 months)
- Frequency of falls(36 months)
- Percent change in lumbar spine bone mineral density(36 months after the start of study drug administration (or at the time of withdrawal from the study))
- Change in proximal femur (total-hip) bone mineral density(36 months after the start of study drug administration (or at the time of withdrawal from the study))
- Percent change in PINP bone metabolism marker(12 months after the start of study drug administration)
研究者
研究点 (1)
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