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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04770506
Other study ID # CHUB-Democles
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2021
Est. completion date June 21, 2022

Study information

Verified date February 2023
Source Brugmann University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 21, 2022
Est. primary completion date June 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Diagnosis of recurrent NL confirmed by URO CT with presence of idiopathic hypercalciuria and metabolic workup available. Exclusion Criteria: People with stones other than calcium (uric acid, cysteine, infectious stones, indinavir stones, primary hyperoxaluria) or with secondary hypercalciuria (primary hyperparathyroidism, sarcoidosis).

Study Design


Intervention

Other:
Data extraction from medical files
Data extraction from medical files

Locations

Country Name City State
Belgium CHU Brugmann Brussels

Sponsors (1)

Lead Sponsor Collaborator
Agnieszka Pozdzik

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 5 minutes
Primary 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. 5 minutes
See also
  Status Clinical Trial Phase
Recruiting NCT03951558 - Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria N/A