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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease-Mineral and Bone Disorder
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Tongji Hospital
      • Contact: yan Xiong, PhD; Phone Number: 027 15549460070; Email: 313857231@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): January 30, 2022

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Nutrition Disorders; Musculoskeletal Diseases; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Bone Diseases, Metabolic; Calcium Metabolism Disorders; Rickets; Vitamin D Deficiency; Hyperparathyroidism, Secondary; Hyperparathyroidism; Kidney Diseases; Renal Insufficiency, Chronic; Bone Diseases; Chronic Kidney Disease-Mineral and Bone Disorder
• Other Study ID Numbers: S094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No