EUCTR2018-003888-56-DK进行中（未招募）1 期
Treatment of adynamic bone disorder with parathyroid hormone in patients with chronic kidney disease
Department of Nephrology, Herlev & Gentofte Hospital, Herlev Hospital0 个研究点目标入组 66 人开始时间: 2020年6月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •? Age =18 years
- •? CKD stage 4-5D (eGFR =2930 ml/min) according to KDIGO (Kidney Disease Improving Global Outcome) definition
- •? DEXA scan with a T-score at the total hip, femoral neck or lumbar spine (L1-4) =-2 (or Z-score =-2) in a minimum of 2 vertebraes and/or former fragility fracture (vertebral, hip, for- or upper arm, ankle) assessed with VFA or x-ray of the columna
- •? Patients with expected adynamic bone disorder, based on BSAP=21 µg/l or biopsy-verified low bone turnover
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •? Hypercalcemia defined as sustained ionized calcium >1.35 mmol/l
- •? Previous fracture within the last 6 months * Patients may be rescreened after the 6 months
- •? Previous calciphylaxis
- •? Thyroid disturbances not adequately treated based on the opinion by the clinician
- •? Treatment with digoxin
- •? Paget’s disease or other metabolic bone disorders
- •? Antiresorptive or bone anabolic medication during the last 24 months (for bisphosphonates it is only during the last 12 months)
- •? Former or present malignant disease (except skin basal or planocellular carcinoma)
- •? Previous external beam or implant radiation therapy to the skeleton
- •? Kidney transplanted patients
- •? Oral prednisolone treatment exceeding a total of 450 mg during the last 6 months or active oral prednisolone treatment with a daily dose of > 5 mg
- •? 25 hydroxyvitamin D2 and D3 <50 nmol/l *Patients may be rescreened after correction
- •? Inability to administer teriparatide
- •? Reduced liver function *ALAT >3x upper limit of normal or bilirubin > 2x upper limit of normal
- •? Pregnancy, lactation or fertile women * Post-menopausal females are not considered fertile not using safe anticonception (the following contraceptive methods are considered appropriate: Intrauterine device (IUD) or hormonal anticontraceptive (oral contraceptives, implant, transdermal patches, vaginal ring or depot injection)).
- •? Hypersensitivity to the active substance in teriparatide or to any of the excipients or content
- •? Inability to provide informed consent
- •? Medical conditions or treatments that may interfere with assessments of the outcomes of the trial
- •? Drug or alcohol abuse
- •? Unable to participate in a clinical study based on the judgement by the local investigator
研究者
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