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

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.

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Key information

Conditions

Chronic Kidney Disease Atrophy Bone Diseases Bone Diseases, Metabolic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Osteoporosis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sarcopenia Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI-FF Scan

Other

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 outcomes

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)

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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangcong Tian, MD

CONTACT

[email protected]

+86 15533929531

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 12, 2026
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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