Clinical trial NCT04564924: To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease With MRI
Official title: To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease Compared to Healthy Volunteers With MRI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease-Mineral and Bone Disorder
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject group:Hospitalized patients in department of Nephrology, Tongji Hospital, Qiaokou District, Wuhan, Hubei, China control group:social recruitment

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.

Eligibility criteria: Inclusion Criteria:

CKD patients aged 18-70 years with free movement

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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 -

Primary outcomes:
measure: Magnetic resonance examination for general diagnosis：routine imaging sequences
timeFrame: 12 months
measure: Magnetic resonance examination to measure tissue diffusion and perfusion：DWI-related sequence
timeFrame: 12 months
measure: Magnetic resonance examination to measure material changes in tissue：CEST
timeFrame: 12 months
measure: Magnetic resonance examination to measure the fat content of tissues：IDEAL- IQ
timeFrame: 12 months
measure: Magnetic resonance examination with ultrashort echo time to imaging musculoskeletal ：UTE
timeFrame: 12 months
measure: Magnetic resonance examination for bone morphological observation: ZTE
timeFrame: 12 months
measure: Magnetic resonance examination to measure changes in the relaxation rate of muscles and blood vessels: SWI
timeFrame: 12 months
measure: Bone mineral density（BMD）measured by DXA
timeFrame: 12 months
measure: Blood biochemistry ：Routine blood was used to detect anemia
timeFrame: 12 months
measure: Blood biochemistry ：renal function was used for staging CKD
timeFrame: 12 months
measure: Blood biochemistry ：Serum electrolyte was used to detect electrolyte changes
timeFrame: 12 months
measure: Blood biochemistry ：the ALP、PTH、25-OH VitD、osteocalcin、T-P1NP and β-CTX were used to detect bone metabolism
timeFrame: 12 months
measure: Blood biochemistry ： blood glucose was used to determine the presence or absence of diabetes
timeFrame: 12 months
measure: Blood biochemistry ：CK(Creatine kinase) was used to detect muscle lesions
timeFrame: 12 months
measure: The urine routine was examined to determine whether individuals in the control group and the experimental group had hematuria and proteinuria
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: