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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCapital Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MRI-FF Scan

    Other intervention

    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.

Treatment groups

868 Participants
are divided into 2 treatment groups
Group A: Chronic Kidney Disease (CKD) Group1 intervention
Group B: Non-CKD Control Group1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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