Metabolic Workup in Patients Suffering From Kidney Stone... | NCT04080973

Studies
Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia

NCT04080973

Sponsor

Ziv Hospital

Status

Unknown status

Last Update Posted

Sep 25, 2019Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Urolithiasis
Renal Colic
Osteopenia

Interventions

CT scan
24 hour urine collection

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2019Estimated

Primary Completion Date

Aug 2020Estimated

Completion Date

Oct 2020Estimated

First Submitted Date

Sep 4, 2019

First Submission Date that Met QC Criteria

Sep 5, 2019

First Posted Date

Sep 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2019

Last Update Posted Date

Sep 25, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
osteopenic patients	Experimental	patients with a kidney stone and osteopenic changes.	Diagnostic Test: CT scan Diagnostic Test: 24 hour urine collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT scan	Diagnostic Test	non contrast spiral CT of the urinary tract including the bony structures of the spine and pelvis	osteopenic patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ran Katz, MD	Contact	97246828775	97246828828	ran.k@ziv.health.gov.il
Yehudit Hackmon	Contact	97246828828	97246828828	yehudit.h@ziv.health.gov.il

Overall Officials

Name	Affiliation	Role
Ran Katz, MD	Ziv Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ran Katz		Safed		1310000	Israel	Ran Katz, MD

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D052878	Urolithiasis
D056844	Renal Colic
D001851	Bone Diseases, Metabolic
D006934	Hypercalcemia
D053565	Hypercalciuria

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014057	Tomography, X-Ray Computed
D059349	Urine Specimen Collection

Ancestor Terms

ID	Term
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided