Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia

Sponsor

Ziv Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04080973

Collaborator

(none)

150

Enrollment

Location

Arm

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urolithiasis Renal Colic Osteopenia	Diagnostic Test: CT scan Diagnostic Test: 24 hour urine collection	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

cohort study of all patients presenting with renal coliccohort study of all patients presenting with renal colic

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Aug 1, 2020

Anticipated Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: osteopenic patients patients with a kidney stone and osteopenic changes.	Diagnostic Test: CT scan non contrast spiral CT of the urinary tract including the bony structures of the spine and pelvis Diagnostic Test: 24 hour urine collection 24 hours collection of urine and measurement of the concentration of calcium, phosphorous, uric acid, oxalate and citrate Other Names: uninalysis

Arm

Intervention/Treatment

Experimental: osteopenic patients

patients with a kidney stone and osteopenic changes.

Diagnostic Test: CT scan

non contrast spiral CT of the urinary tract including the bony structures of the spine and pelvis

Diagnostic Test: 24 hour urine collection

24 hours collection of urine and measurement of the concentration of calcium, phosphorous, uric acid, oxalate and citrate

Other Names:

uninalysis

Outcome Measures

Primary Outcome Measures

correlation between abnormal metabolic changes and abnormal bone density on Ct scan [1 year]
The rate of patients presenting with kidney stones and abnormal bone density and have abnormal urinary clearance of electrolytes.