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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04564924
Enrollment
200
Registered
2020-09-25
Start date
2020-09-02
Completion date
2022-01-30
Last updated
2020-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

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.

Interventions

RADIATIONDXA

Bone mineral density was examined in all cases and controls

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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 -

Design outcomes

Primary

MeasureTime frameDescription
Magnetic resonance examination for general diagnosis:routine imaging sequences12 monthsAll 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 sequence12 monthsAll 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 to measure material changes in tissue:CEST12 monthsAll 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 to measure the fat content of tissues:IDEAL- IQ12 monthsAll 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 with ultrashort echo time to imaging musculoskeletal :UTE12 monthsAll 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)
Magnetic resonance examination for bone morphological observation: ZTE12 monthsAll 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)
Magnetic resonance examination to measure changes in the relaxation rate of muscles and blood vessels: SWI12 monthsAll 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 DXA12 monthsThe dual energy x-ray absorptiometry (DXA) was performed on the lumbar spine of both experimental group and control group.
Blood biochemistry :Routine blood was used to detect anemia12 monthsRoutine blood samples were collected from individuals in the experimental group
Blood biochemistry :renal function was used for staging CKD12 monthsRenal function samples were collected from individuals in the experimental group and control group
Blood biochemistry :Serum electrolyte was used to detect electrolyte changes12 monthsSerum electrolyte 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 metabolism12 monthsThe above serum samples were collected from individuals in the experimental group
Blood biochemistry : blood glucose was used to determine the presence or absence of diabetes12 monthsBlood glucose samples were collected from individuals in the experimental group
Blood biochemistry :CK(Creatine kinase) was used to detect muscle lesions12 monthsCK 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 proteinuria12 monthsThe Routine urine samples were collected from individuals in the experimental group and control group

Countries

China

Contacts

Primary Contactyan Xiong, PhD
313857231@qq.com15549460070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026