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

• Conditions: Chronic Kidney Disease-Mineral and Bone Disorder
• Interventions: Radiation: DXA

• Registration Number: NCT04564924
• Lead Sponsor: Tongji Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-02
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-25
• Last Update Posted: 2020-09-25
• Primary Completion: 2021-09-30
• Study Completion: 2022-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

CKD patients aged 18-70 years with free movement

Exclusion Criteria

1. 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

2. 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

3. MRI contraindications: Intra Uterine Device(iUD), pacemaker, cochlear implant, claustrophobia, etc -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRI & DXA patients	DXA	No intervention
MRI & DXA volunteers	DXA	No intervention

Primary Outcome Measures

Name	Time	Method
Magnetic resonance examination to measure material changes in tissue：CEST	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	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	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	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	12 months	CK samples were collected from individuals in the experimental group
Magnetic resonance examination to measure the fat content of tissues：IDEAL- IQ	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	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	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	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	12 months	Serum electrolyte samples were collected from individuals in the experimental group
Magnetic resonance examination for general diagnosis：routine imaging sequences	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	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	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	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	12 months	The Routine urine samples were collected from individuals in the experimental group and control group

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China