UrolithiasisNCT04080973
Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia
A study testing CT scan and 24 hour urine collection in people with Urolithiasis and Renal Colic, run by Ziv Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Renal Colic, Osteopenia
- What is being tested?
- CT scan and 24 hour urine collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2019to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or old
- informed consent
- kidney stones
- CT scan positive for stones AND bone changes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ran Katz
Safed, 1310000
Ran Katz, MD, 97246828775, ran.k@ziv.health.gov.il
About this study
Official title: 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.
Read the 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.
- Conditions
- Urolithiasis, Renal Colic, Osteopenia
- Being tested
- CT scan, 24 hour urine collection
- Keywords
- urolithiasis, metabolic abnormalities, osteopenia, hypercalcemia, hypercalcuria, bone density
- Medical subject headings
- Urolithiasis, Renal Colic, Bone Diseases, Metabolic, Hypercalcemia, Hypercalciuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
non contrast spiral CT of the urinary tract including the bony structures of the spine and pelvis
24 hour urine collectionDiagnostic test
Also called uninalysis
24 hours collection of urine and measurement of the concentration of calcium, phosphorous, uric acid, oxalate and citrate
| Study group | Role | What they receive |
|---|---|---|
| osteopenic patients | Experimental | patients with a kidney stone and osteopenic changes. Receives: Diagnostic Test: CT scan; Diagnostic Test: 24 hour urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cohort study of all patients presenting with renal colic
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ran Katz, MD, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080973
- Sponsor's protocol ID
- 0141-18-ZIV
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Workup in Patients Suffering From Kidney Stone Disease and Show Osteopenic Bone Changes on Non-contrast CT Scan
- ClinicalTrials.gov ID
- NCT04080973
- Acronym / sponsor ID
- 0141-18-ZIV
- Conditions
- Urolithiasis, Renal Colic, Osteopenia
- Keywords
- urolithiasis, metabolic abnormalities, osteopenia, hypercalcemia, hypercalcuria, bone density
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Oct 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cohort study of all patients presenting with renal colic
| Arm | Type | Receives |
|---|---|---|
| osteopenic patients | Experimental | Diagnostic Test: CT scan, Diagnostic Test: 24 hour urine collectionpatients with a kidney stone and osteopenic changes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or old
- informed consent
- kidney stones
- CT scan positive for stones AND bone changes
Key exclusion criteria (8 listed)
- under 18
- unable to sign
- no stones detected on scan (even if a stone was expelled recently)
- no bone changes
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scannon contrast spiral CT of the urinary tract including the bony structures of the spine and pelvis | Diagnostic test | osteopenic patients |
| 24 hour urine collectionAlso: uninalysis24 hours collection of urine and measurement of the concentration of calcium, phosphorous, uric acid, oxalate and citrate | Diagnostic test | osteopenic patients |
Primary outcome
correlation between abnormal metabolic changes and abnormal bone density on Ct scan
Time frame: 1 year
The rate of patients presenting with kidney stones and abnormal bone density and have abnormal urinary clearance of electrolytes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ran Katz, MD principal investigator
Ziv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan and 24 hour urine collection in people with Urolithiasis and Renal Colic, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran Katz, MD (97246828775 ext. 97246828828, ran.k@ziv.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between abnormal metabolic changes and abnormal bone density on Ct scan (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.