NCT04080973

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 4, 2019

Last Update Submit

September 22, 2019

Conditions

UrolithiasisRenal ColicOsteopenia

Keywords

urolithiasismetabolic abnormalitiesosteopeniahypercalcemiahypercalcuriabone density

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

osteopenic patients

EXPERIMENTAL

patients with a kidney stone and osteopenic changes.

Diagnostic Test: CT scanDiagnostic Test: 24 hour urine collection

Interventions

CT scanDIAGNOSTIC_TEST

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

osteopenic patients
24 hour urine collectionDIAGNOSTIC_TEST

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

Also known as: uninalysis
osteopenic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or old
  • informed consent
  • kidney stones
  • CT scan positive for stones AND bone changes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ran Katz

Safed, 1310000, Israel

Location

MeSH Terms

Conditions

UrolithiasisRenal ColicBone Diseases, MetabolicHypercalcemiaHypercalciuria

Interventions

Tomography, X-Ray ComputedUrine Specimen Collection

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersWater-Electrolyte ImbalanceUrological Manifestations

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomographySpecimen HandlingClinical Laboratory TechniquesInvestigative Techniques

Study Officials

  • Ran Katz, MD

    Ziv Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ran Katz, MD

CONTACT

97246828775ran.k@ziv.health.gov.il

Yehudit Hackmon

CONTACT

97246828828yehudit.h@ziv.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: cohort study of all patients presenting with renal colic
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 6, 2019

Study Start

October 1, 2019

Primary Completion

August 1, 2020

Study Completion

October 1, 2020

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)