To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease With MRI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease Compared to Healthy Volunteers With MRI

Conditions
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Chronic Kidney Disease-Mineral and Bone Disorder

Intervention / Treatment
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* Radiation: DXA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CKD patients aged 18-70 years with free movement - Exclusion Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MRI & DXA patients<br>No intervention | Radiation: DXA<br>* Bone mineral density was examined in all cases and controls<br>|
| MRI & DXA volunteers<br>No intervention | Radiation: DXA<br>* Bone mineral density was examined in all cases and controls<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic resonance examination for general diagnosis：routine imaging sequences | 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. | 12 months | 
| Magnetic resonance examination to measure tissue diffusion and perfusion：DWI-related sequence | 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 | 12 months | 
| Magnetic resonance examination to measure material changes in tissue：CEST | 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) | 12 months | 
| Magnetic resonance examination to measure the fat content of tissues：IDEAL- IQ | 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) | 12 months | 
| Magnetic resonance examination with ultrashort echo time to imaging musculoskeletal ：UTE | 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) | 12 months | 
| Magnetic resonance examination for bone morphological observation: ZTE | 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) | 12 months | 
| Magnetic resonance examination to measure changes in the relaxation rate of muscles and blood vessels: SWI | 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) | 12 months | 
| Bone mineral density（BMD）measured by DXA | The dual energy x-ray absorptiometry (DXA) was performed on the lumbar spine of both experimental group and control group. | 12 months | 
| Blood biochemistry ：Routine blood was used to detect anemia | Routine blood samples were collected from individuals in the experimental group | 12 months | 
| Blood biochemistry ：renal function was used for staging CKD | Renal function samples were collected from individuals in the experimental group and control group | 12 months | 
| Blood biochemistry ：Serum electrolyte was used to detect electrolyte changes | Serum electrolyte samples were collected from individuals in the experimental group | 12 months | 
| Blood biochemistry ：the ALP、PTH、25-OH VitD、osteocalcin、T-P1NP and β-CTX were used to detect bone metabolism | The above serum samples were collected from individuals in the experimental group | 12 months | 
| Blood biochemistry ： blood glucose was used to determine the presence or absence of diabetes | Blood glucose samples were collected from individuals in the experimental group | 12 months | 
| Blood biochemistry ：CK(Creatine kinase) was used to detect muscle lesions | CK samples were collected from individuals in the experimental group | 12 months | 
| The urine routine was examined to determine whether individuals in the control group and the experimental group had hematuria and proteinuria | The Routine urine samples were collected from individuals in the experimental group and control group | 12 months |