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

Observational Chronic Kidney Disease Osteoporosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI-FF Scan.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease, Osteoporosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Clinical Study on Establishing a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Patients With Chronic Kidney Disease Based on MRI-FFR

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.

Interventions

  • Other MRI-FF Scan
    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.

Primary outcome measures

  • Correlation between MRI-FF-derived bone mineral density and DXA measurements [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 [Time frame: At the time of the MRI-FF scan (baseline, one-time assessment)]

Eligibility criteria

Inclusion criteria

  • 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).
  • For control group: No history of chronic kidney disease and normal renal function.

Exclusion criteria

  • 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.
  • Inability to cooperate with the scan due to cognitive impairment or severe illness.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07645794 · 2026-2-1064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗