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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07645794

Enrollment

868

Registered

2026-06-12

Start date

2026-06-01

Completion date

2028-12-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Osteoporosis

Keywords

Chronic Kidney Disease, Osteoporosis, Sarcopenia, MRI-FF, Bone Mineral Density, Muscle Fat Fraction

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.

Interventions

OTHERMRI-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Correlation between MRI-FF-derived bone mineral density and DXA measurements	At the time of the MRI-FF scan (baseline, one-time assessment)	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	At the time of the MRI-FF scan (baseline, one-time assessment)	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.

Contacts

CONTACTXiangcong Tian, MD

811214402@qq.com+86 15533929531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026