To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease Compared to Healthy Volunteers With MRI
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Magnetic resonance examination to measure material changes in tissue：CEST
研究概览
简要总结
Patients with chronic kidney disease (CKD) have a higher risk of fractures than those without. The purpose of this study is to develop a non-invasive Magnetic resonance imaging (MRI) method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.
详细描述
Chronic Kidney Disease-Mineral and Bone Disorder (MBD） is a common complication of chronic kidney disease (CKD), which may lead to defective mineralization, altered bone morphology, and/or bone turnover. Animal research found that bone changes occur even in the early stage of CKD , and with CKD progression, the patient may show symptoms such as bone pain, joint pain, bone deformation, and even spontaneous fractures.
Despite significant advances in understanding bone disease in CKD, most clinical and biochemical targets used in clinical practice remain controversial, resulting in an undermanagement of bone fragility.Our ability to diagnose CKD-MBD and to initiate strategies that could prevent fractures remains limited by the lack of accurate and noninvasive diagnostic tools.
The purpose of this study is to develop a non-invasive method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CKD patients aged 18-70 years with free movement
排除标准
- •The following diseases: rickets, osteomalacia, Paget's disease, acromegaly, scurvy (vitamin C deficiency), hyperthyroidism, history of malignant tumors, received radiotherapy and chemotherapy, fractures within 6 months, lumbar and calf trauma surgery, scoliosis, rheumatic immunity disease, anorexia nervosa, motor neuron disease
- •Treated with the following drugs within two years:
- •A) Bisphosphonates: Alendronate , etidronate , Ibandronate, rithiadronate, and zoledronate B) Steroid hormones: estrogen replacement agents , isoflavone derivatives , estrogen, progesterone C) Oral glucocorticoids: prednisone , Prednisone D) Salmon calcitonin
- •MRI contraindications: Intra Uterine Device(iUD), pacemaker, cochlear implant, claustrophobia, etc -
结局指标
主要结局
Magnetic resonance examination to measure material changes in tissue：CEST
时间窗: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence: chemical exchange saturation transfer(CEST)
Magnetic resonance examination with ultrashort echo time to imaging musculoskeletal ：UTE
时间窗: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group. And the full abbreviation of the above sequence: ultrashort echo time (UTE)
Blood biochemistry ： blood glucose was used to determine the presence or absence of diabetes
时间窗: 12 months
Blood glucose samples were collected from individuals in the experimental group
Blood biochemistry ：the ALP、PTH、25-OH VitD、osteocalcin、T-P1NP and β-CTX were used to detect bone metabolism
时间窗: 12 months
The above serum samples were collected from individuals in the experimental group
Blood biochemistry ：CK(Creatine kinase) was used to detect muscle lesions
时间窗: 12 months
CK samples were collected from individuals in the experimental group
Magnetic resonance examination to measure the fat content of tissues：IDEAL- IQ
时间窗: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence：iterative decomposition of water and fat with echo asymmetry and least-squares estimation (IDEAL) - intelligent quantification (IQ)
Magnetic resonance examination to measure changes in the relaxation rate of muscles and blood vessels: SWI
时间窗: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lower legs of both experimental group and control group. And the full abbreviation of the above sequence: Susceptibility-weighted Imaging(SWI)
Bone mineral density（BMD）measured by DXA
时间窗: 12 months
The dual energy x-ray absorptiometry (DXA) was performed on the lumbar spine of both experimental group and control group.
Blood biochemistry ：renal function was used for staging CKD
时间窗: 12 months
Renal function samples were collected from individuals in the experimental group and control group
Blood biochemistry ：Serum electrolyte was used to detect electrolyte changes
时间窗: 12 months
Serum electrolyte samples were collected from individuals in the experimental group
Magnetic resonance examination for general diagnosis：routine imaging sequences
时间窗: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.
Magnetic resonance examination to measure tissue diffusion and perfusion：DWI-related sequence
时间窗: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence:Diffusion Weighted Imaging(DWI)-related sequence
Magnetic resonance examination for bone morphological observation: ZTE
时间窗: 12 months
All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lower legs of both experimental group and control group.And the full abbreviation of the above sequence: Zero-Echo Time(ZTE)
Blood biochemistry ：Routine blood was used to detect anemia
时间窗: 12 months
Routine blood samples were collected from individuals in the experimental group
The urine routine was examined to determine whether individuals in the control group and the experimental group had hematuria and proteinuria
时间窗: 12 months
The Routine urine samples were collected from individuals in the experimental group and control group
次要结局
未报告次要终点