Clinical Study on a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Chronic Kidney Disease Patients Based on MRI-FF

N/ANot Yet RecruitingNCT07645794

Capital Medical University868 enrolled

Overview

This is a single-center, observational cohort study aiming to validate the diagnostic value of MRI-FF in identifying osteoporosis and sarcopenia in patients with chronic kidney disease (CKD). A total of 868 participants, including 434 CKD patients and 434 non-CKD controls, will be enrolled at Beijing Jishuitan Hospital. All subjects will undergo MRI-FF scans of the lumbar spine and thigh to assess bone mineral density and muscle fat fraction. The primary objective is to evaluate the correlation between MRI-FF parameters and conventional diagnostic criteria for osteoporosis and sarcopenia, as well as to determine the optimal cut-off values for early detection. The study duration is from March 2026 to December 2028.

Study Type

OBSERVATIONAL

Enrollment

868

Conditions

Chronic Kidney Disease Osteoporosis

Interventions

MRI-FF ScanOTHER

MRI fat-fraction (MRI-FF) scan of the lumbar spine and thigh, performed once for all participants to assess bone mineral density and muscle fat fraction.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 and 80 years old. 2. Able to understand and sign the informed consent form. 3. Able to complete MRI-FF scans of the lumbar spine and thigh. 4. For CKD group: Confirmed diagnosis of chronic kidney disease (eGFR \< 60 mL/min/1.73m² for ≥3 months). 5. For control group: No history of chronic kidney disease and normal renal function. Exclusion Criteria: 1. Contraindications to MRI (e.g., pacemaker, metal implants, severe claustrophobia). 2. History of primary bone metabolic disorders (e.g., osteoporosis, hyperparathyroidism) unrelated to CKD. 3. Current use of anti-osteoporotic drugs (e.g., bisphosphonates, teriparatide). 4. Severe lower limb deformity or amputation affecting thigh muscle assessment. 5. Inability to cooperate with the scan due to cognitive impairment or severe illness.

Outcomes

Primary Outcomes

Correlation between MRI-FF-derived bone mineral density and DXA measurements

The primary outcome is the correlation coefficient between MRI fat-fraction (MRI-FF) parameters and standard dual-energy X-ray absorptiometry (DXA) bone mineral density values in the lumbar spine of CKD patients and controls.

Time frame: At the time of the MRI-FF scan (baseline, one-time assessment)

Diagnostic performance of MRI-FF for sarcopenia using muscle fat fraction

The secondary outcome is the diagnostic accuracy (sensitivity, specificity, AUC) of MRI-FF-derived thigh muscle fat fraction in identifying sarcopenia, based on standard diagnostic criteria.