A Clinical Study on Establishing a New Diagnostic Strategy for Osteoporosis and Sarcopenia in Patients With Chronic Kidney Disease Based on MRI-FFR
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 868
- 试验地点
- 1
- 主要终点
- Correlation between MRI-FF-derived bone mineral density and DXA measurements
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: MRI-FF Scan (Other)
结局指标
主要结局
Correlation between MRI-FF-derived bone mineral density and DXA measurements
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Dongliang Zhang, MD
Chief Physician, Professor, Department of Nephrology
Capital Medical University