About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 18 and 80 years old.
Able to understand and sign the informed consent form.
Able to complete MRI-FF scans of the lumbar spine and thigh.
For CKD group: Confirmed diagnosis of chronic kidney disease (eGFR < 60 mL/min/1.73m² for ≥3 months).
Disqualifiers
Contraindications to MRI (e.g., pacemaker, metal implants, severe claustrophobia).
History of primary bone metabolic disorders (e.g., osteoporosis, hyperparathyroidism) unrelated to CKD.
Current use of anti-osteoporotic drugs (e.g., bisphosphonates, teriparatide).
Severe lower limb deformity or amputation affecting thigh muscle assessment.
Trial population
The study population consists of two groups: 434 patients with chronic kidney disease (CKD) and 434 age- and sex-matched healthy controls without CKD. All participants are adults aged 18-80 years old who are able to complete the required MRI scans.
Trial design
Cohort
Prospective
Treatments tested in this trial
MRI-FF Scan
Other interventionMRI 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.
Treatment groups
Trial 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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: