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

NCT07645794 | Not Yet Recruiting

• 1 other identifier: 2026-2-1064
• Study Type: observational
• Target: 868
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease; Osteoporosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Study Arms (2)

Chronic Kidney Disease (CKD) Group

Patients with chronic kidney disease (CKD) who undergo MRI-FF scans of the lumbar spine and thigh to evaluate bone mineral density and muscle fat fraction.

Other: MRI-FF Scan

Non-CKD Control Group

Control participants without chronic kidney disease, undergoing the same MRI-FF scans as the CKD group for comparison.

Other: MRI-FF Scan

Interventions

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.

Chronic Kidney Disease (CKD) Group; Non-CKD Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Osteoporosis; Sarcopenia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiangcong Tian, MD

CONTACT

+86 15533929531; 811214402@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor, Department of Nephrology

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share