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

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ClinicalTrials.gov Identifier: NCT04564924
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
yan Xiong, Tongji Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Chronic Kidney Disease-Mineral and Bone Disorder Radiation: DXA

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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease Compared to Healthy Volunteers With MRI
Actual Study Start Date : September 2, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
MRI & DXA patients
No intervention
 Radiation: DXA
Bone mineral density was examined in all cases and controls
MRI & DXA volunteers
No intervention
 Radiation: DXA
Bone mineral density was examined in all cases and controls


Outcome Measures
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Primary Outcome Measures :
  1. Magnetic resonance examination for general diagnosis：routine imaging sequences [ Time Frame: 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.

  2. Magnetic resonance examination to measure tissue diffusion and perfusion：DWI-related sequence [ Time Frame: 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

  3. Magnetic resonance examination to measure material changes in tissue：CEST [ Time Frame: 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)

  4. Magnetic resonance examination to measure the fat content of tissues：IDEAL- IQ [ Time Frame: 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)

  5. Magnetic resonance examination with ultrashort echo time to imaging musculoskeletal ：UTE [ Time Frame: 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)

  6. Magnetic resonance examination for bone morphological observation: ZTE [ Time Frame: 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)

  7. Magnetic resonance examination to measure changes in the relaxation rate of muscles and blood vessels: SWI [ Time Frame: 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)

  8. Bone mineral density（BMD）measured by DXA [ Time Frame: 12 months ]
    The dual energy x-ray absorptiometry (DXA) was performed on the lumbar spine of both experimental group and control group.

  9. Blood biochemistry ：Routine blood was used to detect anemia [ Time Frame: 12 months ]
    Routine blood samples were collected from individuals in the experimental group

  10. Blood biochemistry ：renal function was used for staging CKD [ Time Frame: 12 months ]
    Renal function samples were collected from individuals in the experimental group and control group

  11. Blood biochemistry ：Serum electrolyte was used to detect electrolyte changes [ Time Frame: 12 months ]
    Serum electrolyte samples were collected from individuals in the experimental group

  12. Blood biochemistry ：the ALP、PTH、25-OH VitD、osteocalcin、T-P1NP and β-CTX were used to detect bone metabolism [ Time Frame: 12 months ]
    The above serum samples were collected from individuals in the experimental group

  13. Blood biochemistry ： blood glucose was used to determine the presence or absence of diabetes [ Time Frame: 12 months ]
    Blood glucose samples were collected from individuals in the experimental group

  14. Blood biochemistry ：CK(Creatine kinase) was used to detect muscle lesions [ Time Frame: 12 months ]
    CK samples were collected from individuals in the experimental group

  15. The urine routine was examined to determine whether individuals in the control group and the experimental group had hematuria and proteinuria [ Time Frame: 12 months ]
    The Routine urine samples were collected from individuals in the experimental group and control group


Biospecimen Retention:   Samples Without DNA
Urine, serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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 -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564924


Contacts
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Contact: yan Xiong, PhD 15549460070 ext 027 313857231@qq.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: yan Xiong, PhD    15549460070 ext 027    313857231@qq.com   
Sponsors and Collaborators
Tongji Hospital
More Information
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Responsible Party: yan Xiong, PhD, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04564924    
Other Study ID Numbers: S094
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Diseases
Chronic Kidney Disease-Mineral and Bone Disorder
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Musculoskeletal Diseases
Rickets
Bone Diseases, Metabolic
Metabolic Diseases
 Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases