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Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia

Primary Purpose

Urolithiasis, Renal Colic, Osteopenia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CT scan
24 hour urine collection
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urolithiasis focused on measuring urolithiasis, metabolic abnormalities, osteopenia, hypercalcemia, hypercalcuria, bone density

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ran Katz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

osteopenic patients

Arm Description

patients with a kidney stone and osteopenic changes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2019
Last Updated
September 22, 2019
Sponsor
Ziv Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04080973
Brief Title
Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia
Official Title
Metabolic Workup in Patients Suffering From Kidney Stone Disease and Show Osteopenic Bone Changes on Non-contrast CT Scan
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis, Renal Colic, Osteopenia
Keywords
urolithiasis, metabolic abnormalities, osteopenia, hypercalcemia, hypercalcuria, bone density

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cohort study of all patients presenting with renal colic
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
osteopenic patients
Arm Type
Experimental
Arm Description
patients with a kidney stone and osteopenic changes.
Intervention Type
Diagnostic Test
Intervention Name(s)
CT scan
Intervention Description
non contrast spiral CT of the urinary tract including the bony structures of the spine and pelvis
Intervention Type
Diagnostic Test
Intervention Name(s)
24 hour urine collection
Other Intervention Name(s)
uninalysis
Intervention Description
24 hours collection of urine and measurement of the concentration of calcium, phosphorous, uric acid, oxalate and citrate
Primary Outcome Measure Information:
Title
correlation between abnormal metabolic changes and abnormal bone density on Ct scan
Description
The rate of patients presenting with kidney stones and abnormal bone density and have abnormal urinary clearance of electrolytes.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Katz, MD
Phone
97246828775
Ext
97246828828
Email
ran.k@ziv.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yehudit Hackmon
Phone
97246828828
Ext
97246828828
Email
yehudit.h@ziv.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Katz, MD
Organizational Affiliation
Ziv Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ran Katz
City
Safed
ZIP/Postal Code
1310000
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Katz, MD
Phone
97246828775
Email
ran.k@ziv.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

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Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia

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