TCTR20190725001招募中3 期
Precision treatment for Renal Osteodystrophy Guided by Bone Histomorphometry in Hemodialysis Patient with Low Bone Mineral Density
Faculty of Medicine, Chulalongkorn University0 个研究点目标入组 80 人开始时间: 2019年7月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
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
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1.Adult (Age ≥18-year-old)
- •2.End-stage renal disease on chronic hemodialysis ≥ 3 months
- •3.BMD T-score at the total hip, femoral neck, lumbar spine or distal forearm ≤ -2.5 or ≤ -1.0 with a presence of previous fragility fracture
- •4.Serum intact parathyroid hormone (iPTH) level between 150 to 800 picogram per milliliter
- •5.Tetracycline double-labelled trans-iliac bone biopsy with Histomorphometry
- •shown - low bone turnover disease (ABD) for Arm A and - high bone turnover disease for Arm B
排除标准
- •1.Active malignancy or history of primary or secondary neoplasm of bone
- •2.Bleeding tendency defined by: platelet counts < 150,000 per microliters, prolonged prothrombin time (PT) > 3 sec from normal control or activated partial thromboplastin time (APTT) > 2 times of normal control or currently taking anticoagulation or antiplatelets.
- •3.Chronic heart failure, arrhythmias or chronic lung disease patient who unable to do prone position while biopsy procedure.
- •4.History of allergy or severe adverse reaction to tetracycline and meperidine
- •5.Pregnancy or breastfeeding
- •6.Presence of connective tissue or bone disease affected in bone fragility e.g. rheumatoid arthritis, osteomalacia, chronic steroid use (prednisolone > 20mg/d for> 90 days)
- •7.Presence of multiple prosthesis which unable to measure at least 1 site of DXA-BMD
- •8.Current or previous use of osteoporosis medications.
- •9.Presence of other cause of bone abnormality e.g. Aluminum toxicity, mixed renal osteodystrophy according to bone histology.
- •10.History of allergy or severe adverse reaction to teriparatide and lanthanum (for arm A) and cinacalcet and calcitriol (for arm B)
- •11.Corrected QT interval frome 12-leads EKG more than 500 milisecconds (for arm B)
- •12.Anticipated living donor kidney transplant within study period
研究者
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