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临床试验/NCT04080973
NCT04080973Unknown不适用

Metabolic Workup in Patients Suffering From Kidney Stone Disease and Show Osteopenic Bone Changes on Non-contrast CT Scan

Ziv Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
correlation between abnormal metabolic changes and abnormal bone density on Ct scan

研究概览

简要总结

Patients suffering from acute renal colic are evaluated by non contrast computerized tomography with excellent identification rates of urinary stones. The scan also covers the bones of the ribs, spine and pelvis, allowing measurements of the bone density and identifying early osteopenic changes. Bone demineralization is associated with metabolic changes such as hypercalcemia or hypercalcuria. In this study the investigators will look for correlation between kidney stones, osteopenic bone changes and metabolic abnormalities.

详细描述

Kidney stones are a common medical condition found in more then 5% of the adult population. The stones might cause severe pain (due to acute obstruction of a renal unit) , deterioration of renal function and urinary tract infection. One of the causes of kidney stones is metabolic changes such as hypercalcemia or hyperoxaluria. Basic evaluation of kidney stones patients include measurements of calcium, phosphor and uric acid in the serum and is often negative. Thorough metabolic workup including 24 hours urine collection is not cost effective and is reserved for patients with frequent recurrence of stone disease.

Metabolic abnormalities are often associated with bone demineralization, of which the patients are typically unaware. such changes can be detected by the CT scan. On the same scan, performed for identifying the stone, the radiologist can measure bone density, using the Hounsfield units, in the L2 vertebral body of and the acetabular area of the pelvis.

In the study, in all patients undergoing CT scan due to renal colic, the bone density will be measured. Patients with abnormal bone density will undergo a complete metabolic workup including 24 hours collection of urine and measurements of urinary clearance of calcium, phosphorous, uric acid, oxalate and citrate . The investigators will look for correlation between osteopenic changes and metabolic abnormalities.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or old
  • informed consent
  • kidney stones
  • CT scan positive for stones AND bone changes

排除标准

  • unable to sign
  • no stones detected on scan (even if a stone was expelled recently)
  • no bone changes
  • pregnancy
  • a patient already known to suffer from metabolic bone disease
  • a patient with documented osteoporosis
  • patients following spinal or pelvic trauma / surgery

研究组 & 干预措施

osteopenic patients

Experimental

patients with a kidney stone and osteopenic changes.

干预措施: CT scan (Diagnostic Test)

osteopenic patients

Experimental

patients with a kidney stone and osteopenic changes.

干预措施: 24 hour urine collection (Diagnostic Test)

结局指标

主要结局

correlation between abnormal metabolic changes and abnormal bone density on Ct scan

时间窗: 1 year

The rate of patients presenting with kidney stones and abnormal bone density and have abnormal urinary clearance of electrolytes.

次要结局

未报告次要终点

研究者

发起方
Ziv Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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