Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04080973
• Other study ID #: 0141-18-ZIV
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2019
• Est. completion date: October 2020

Study information

• Verified date: September 2019
• Source: Ziv Hospital
• Contact: Ran Katz, MD
• Phone: 97246828775
• Email: ran.k[@]ziv.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or old

• informed consent

• kidney stones

• CT scan positive for stones AND bone changes

Exclusion Criteria:

• under 18

• 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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Kidney Calculi
• Osteopenia
• Renal Colic
• Urolithiasis

Intervention

Diagnostic Test:
• CT scan
non contrast spiral CT of the urinary tract including the bony structures of the spine and pelvis
• 24 hour urine collection
24 hours collection of urine and measurement of the concentration of calcium, phosphorous, uric acid, oxalate and citrate

Locations

Country	Name	City	State
Israel	Ran Katz	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation between abnormal metabolic changes and abnormal bone density on Ct scan	The rate of patients presenting with kidney stones and abnormal bone density and have abnormal urinary clearance of electrolytes.	1 year