A Clinical Study on Establishing a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Patients With Chronic Kidney Disease Based on MRI-FFR
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 868
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Investigators
Dongliang Zhang, MD
Chief Physician, Professor, Department of Nephrology
Capital Medical University