Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia

NCT ID: NCT04080973

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-31

Study Completion Date

2020-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urolithiasis Renal Colic Osteopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

cohort study of all patients presenting with renal colic
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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osteopenic patients

patients with a kidney stone and osteopenic changes.

Group Type EXPERIMENTAL

CT scan

Intervention Type DIAGNOSTIC_TEST

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

24 hour urine collection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CT scan

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

Intervention Type DIAGNOSTIC_TEST

24 hour urine collection

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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uninalysis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziv Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ran Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Medical Center

Locations

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Ran Katz

Safed, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ran Katz, MD

Role: CONTACT

97246828775 ext. 97246828828

Yehudit Hackmon

Role: CONTACT

97246828828 ext. 97246828828

Facility Contacts

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Ran Katz, MD

Role: primary

97246828775

Other Identifiers

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0141-18-ZIV

Identifier Type: -

Identifier Source: org_study_id

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