Hypercalciuria; IdiopathicNCT04770506
Bone Mineral Density and Vascular Calcifications in the Population of Lithiasis Patients With Idiopathic Hypercalciuria
An observational study of Hypercalciuria; Idiopathic, run by Agnieszka Pozdzik at 1 site in Belgium.
Trial summary
In industrialized countries, it is estimated that around 10% of the population suffers from nephrolithiasis (NL). Numerous recent epidemiological studies report that the prevalence and incidence of NL continue to increase, with a prevalence that has nearly doubled over the past two decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercalciuria; Idiopathic
- What is being tested?
- Data extraction from medical files
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jan 2021to 21 Jun 2022
- Phase
- Observational
- 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
Study population: Diagnosis of recurrent NL confirmed by URO CT with presence of idiopathic hypercalciuria and metabolic workup available.
Who may be able to join
- Diagnosis of recurrent NL confirmed by URO CT with presence of idiopathic hypercalciuria and metabolic workup available.
Who cannot join
- People with stones other than calcium (uric acid, cysteine, infectious stones, indinavir stones, primary hyperoxaluria) or with secondary hypercalciuria (primary hyperparathyroidism, sarcoidosis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Interventional Study of Bone Mineral Density and Vascular Calcifications in the Population of Lithiasis Patients With Idiopathic Hypercalciuria
In industrialized countries, it is estimated that around 10% of the population suffers from nephrolithiasis (NL). Numerous recent epidemiological studies report that the prevalence and incidence of NL continue to increase, with a prevalence that has nearly doubled over the past two decades. A patient who presented with a first episode of renal lithiasis has an estimated recurrence rate of nearly 50% at 5 years in adults. It is therefore wiser to consider NL as a chronic pathology and not as a simple isolated attack of painful crisis. NL therefore represents a real public health problem with a significant impact on the quality of life of patients, with considerable socio-economic repercussions.
In clinical practice, calcium lithiasis is the most common and occurs in 90% of cases.The stones mainly consist of calcium oxalate (whewellite, weddellite) but also calcium phosphate (carbapatite, brushite).
Read more
One of the risk factors for calcium lithiasis is the over-saturation of urine with calcium, which can lead to crystal formation.
The most common metabolic abnormality found in patients with NL is hypercalciuria.It is defined as an increased excretion of urinary calcium.We can first distinguish hypercalciuria secondary to another pathology such as primary hyperparathyroidism, sarcoidosis, distal tubular acidosis, hypervitaminosis D, immobilization... from idiopathic hypercalciuria (HI), at the origin of so-called primary calcium lithiasis.HI is estimated to affect 30-60% of adults with NL.
Idiopathic hypercalciuria is associated with low bone mineral density. Patients with NL have significantly lower T-score values in the vertebrae, hips, and femoral necks.Patients with NL have an increased risk of fractures and are 4 times more likely to develop osteoporosis. It is currently proposed that idiopathic hypercalciuria may be the cause of the decrease in bone mineral density in lithiasis patients.This bone demineralization appears to be associated with an increase in vascular calcifications.These, like NL, are believed to be linked to extra-osia calcium deposits.There is an inverse relationship between bone mineral density and arterial wall thickness (partly due to vascular calcifications) suggesting a relationship between arteriosclerosis and osteoporosis. This relationship would be much more pronounced in lithiasis women. In addition, several observations report an increase in cardiovascular morbidity in people with NL.
NL should therefore be seen as a systemic disease and is also associated with several pathologies such as: metabolic syndrome, arterial hypertension, diabetes and cardiovascular diseases.
To the knowledge of the investigators, no statistical data concerning the prevalence of vascular calcifications and bone demineralization in the population of lithiasis patients in Belgium has been published to date.
In this context, the aim of this study is to assess the prevalence of vascular calcifications (early state of arteriosclerosis) as well as the bone mineral density in the lithiasis population followed at the Brugmann University Hospital and with idiopathic hypercalciuria.
- Conditions
- Hypercalciuria; Idiopathic
- Being tested
- Data extraction from medical files
- Medical subject headings
- Hypercalciuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
| Study group | Role | What they receive |
|---|---|---|
| Lithiasis patients | Lithiasis patients: diagnosis of recurrent NL confirmed by URO CT with presence of idiopathic hypercalciuria and metabolic workup available. Receives: Other: Data extraction from medical files | |
| Control group | Control group: patients without NL matched for age and sex and who had a bone mineral densitometry or abdominal CT. Receives: Other: Data extraction from medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-score
The T score is an indicator of bone mass provided by the dual energy x-ray absorptiometry (DXA) technique. The results are classified into four levels. Level 1: normal bone mass, level 2: osteopenia, level 3: osteoporosis, level 4: severe osteoporosis.
Measured: 5 minutes
Aortic calcification index (ACI)
Estimations of aortic calcification are performed by abdominal computed tomography. ACI (%) = (total calcification score in all slices) / 12 (number of segments in each slice) x 10 (number of slices) x 100.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start12 Jan 2021
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercalciuria; IdiopathicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agnieszka Pozdzik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Agnieszka Pozdzik, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770506
- Sponsor's protocol ID
- CHUB-Democles
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2021
- Last updated
- 9 Feb 2023
- 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 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Interventional Study of Bone Mineral Density and Vascular Calcifications in the Population of Lithiasis Patients With Idiopathic Hypercalciuria
- ClinicalTrials.gov ID
- NCT04770506
- Acronym / sponsor ID
- CHUB-Democles
- Conditions
- Hypercalciuria; Idiopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Agnieszka PozdzikUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 25 Feb 2021 (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.
In industrialized countries, it is estimated that around 10% of the population suffers from nephrolithiasis (NL). Numerous recent epidemiological studies report that the prevalence and incidence of NL continue to increase, with a prevalence that has nearly doubled over the past two decades. A patient who presented with a first episode of renal lithiasis has an estimated recurrence rate of nearly 50% at 5 years in adults. It is therefore wiser to consider NL as a chronic pathology and not as a simple isolated attack of painful crisis. NL therefore represents a real public health problem with a significant impact on the quality of life of patients, with considerable socio-economic repercussions.
In clinical practice, calcium lithiasis is the most common and occurs in 90% of cases.The stones mainly consist of calcium oxalate (whewellite, weddellite) but also calcium phosphate (carbapatite, brushite).
One of the risk factors for calcium lithiasis is the over-saturation of urine with calcium, which can lead to crystal formation.
The most common metabolic abnormality found in patients with NL is hypercalciuria.It is defined as an increased excretion of urinary calcium.We can first distinguish hypercalciuria secondary to another pathology such as primary hyperparathyroidism, sarcoidosis, distal tubular acidosis, hypervitaminosis D, immobilization... from idiopathic hypercalciuria (HI), at the origin of so-called primary calcium lithiasis.HI is estimated to affect 30-60% of adults with NL.
Idiopathic hypercalciuria is associated with low bone mineral density. Patients with NL have significantly lower T-score values in the vertebrae, hips, and femoral necks.Patients with NL have an increased risk of fractures and are 4 times more likely to develop osteoporosis. It is currently proposed that idiopathic hypercalciuria may be the cause of the decrease in bone mineral density in lithiasis patients.This bone demineralization appears to be associated with an increase in vascular calcifications.These, like NL, are believed to be linked to extra-osia calcium deposits.There is an inverse relationship between bone mineral density and arterial wall thickness (partly due to vascular calcifications) suggesting a relationship between arteriosclerosis and osteoporosis. This relationship would be much more pronounced in lithiasis women. In addition, several observations report an increase in cardiovascular morbidity in people with NL.
NL should therefore be seen as a systemic disease and is also associated with several pathologies such as: metabolic syndrome, arterial hypertension, diabetes and cardiovascular diseases.
To the knowledge of the investigators, no statistical data concerning the prevalence of vascular calcifications and bone demineralization in the population of lithiasis patients in Belgium has been published to date.
In this context, the aim of this study is to assess the prevalence of vascular calcifications (early state of arteriosclerosis) as well as the bone mineral density in the lithiasis population followed at the Brugmann University Hospital and with idiopathic hypercalciuria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithiasis patients | – | Other: Data extraction from medical filesLithiasis patients: diagnosis of recurrent NL confirmed by URO CT with presence of idiopathic hypercalciuria and metabolic workup available. |
| Control group | – | Other: Data extraction from medical filesControl group: patients without NL matched for age and sex and who had a bone mineral densitometry or abdominal CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of recurrent NL confirmed by URO CT with presence of idiopathic hypercalciuria and metabolic workup available.
Key inclusion criteria (1 listed)
- Diagnosis of recurrent NL confirmed by URO CT with presence of idiopathic hypercalciuria and metabolic workup available.
Key exclusion criteria (1 listed)
- People with stones other than calcium (uric acid, cysteine, infectious stones, indinavir stones, primary hyperoxaluria) or with secondary hypercalciuria (primary hyperparathyroidism, sarcoidosis).
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 |
|---|---|---|
| Data extraction from medical filesData extraction from medical files | Other | Control group, Lithiasis patients |
Primary outcome
T-score
Time frame: 5 minutes
The T score is an indicator of bone mass provided by the dual energy x-ray absorptiometry (DXA) technique. The results are classified into four levels. Level 1: normal bone mass, level 2: osteopenia, level 3: osteoporosis, level 4: severe osteoporosis.
Aortic calcification index (ACI)
Time frame: 5 minutes
Estimations of aortic calcification are performed by abdominal computed tomography. ACI (%) = (total calcification score in all slices) / 12 (number of segments in each slice) x 10 (number of slices) x 100.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercalciuria; Idiopathic, run by Agnieszka Pozdzik at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Feb 2023. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-score (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 9 Feb 2023.