Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia

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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Colic; Urolithiasis; Osteopenia
• Intervention / Treatment: Diagnostic test: CT scan; Diagnostic test: 24 hour urine collection

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ran Katz, MD; Phone Number: 97246828828 97246828775; Email: ran.k@ziv.health.gov.il
• Study Contact Backup: Name: Yehudit Hackmon; Phone Number: 97246828828 97246828828; Email: yehudit.h@ziv.health.gov.il

Study Locations

• Israel
  • Safed, Israel, 1310000
    • Ran Katz
    • Contact: Ran Katz, MD; Phone Number: 97246828775; Email: ran.k@ziv.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ziv Hospital
• Investigators: Principal Investigator: Ran Katz, MD, Ziv Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (ACTUAL): September 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 22, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: bone density; urolithiasis; osteopenia; hypercalcemia; metabolic abnormalities; hypercalcuria
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Calculi; Nephrolithiasis; Renal Colic; Urinary Calculi; Urolithiasis; Bone Diseases, Metabolic; Kidney Calculi
• Other Study ID Numbers: 0141-18-ZIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No