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

Chronic Kidney Disease-Mineral and Bone Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04564924
• Other study ID #: S094
• Status: Recruiting
• Start date: September 2, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: September 2020
• Source: Tongji Hospital
• Contact: yan Xiong, PhD
• Phone: 15549460070
• Email: 313857231[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Bone Diseases
• Chronic Kidney Disease-Mineral and Bone Disorder
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Radiation:
• DXA
Bone mineral density was examined in all cases and controls

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Blood biochemistry :Routine blood was used to detect anemia	Routine blood samples were collected from individuals in the experimental group	12 months
Primary	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
Primary	Blood biochemistry :Serum electrolyte was used to detect electrolyte changes	Serum electrolyte samples were collected from individuals in the experimental group	12 months
Primary	Blood biochemistry :the ALP?PTH?25-OH VitD?osteocalcin?T-P1NP and ß-CTX were used to detect bone metabolism	The above serum samples were collected from individuals in the experimental group	12 months
Primary	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
Primary	Blood biochemistry :CK(Creatine kinase) was used to detect muscle lesions	CK samples were collected from individuals in the experimental group	12 months
Primary	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