Bone Mineral Density and Vascular Calcifications in the Population of Lithiasis Patients With Idiopathic Hypercalciuria

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).

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 Overview

• Status: Completed
• Conditions: Hypercalciuria; Idiopathic
• Intervention / Treatment: Other: Data extraction from medical files

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of recurrent NL confirmed by URO CT with presence of idiopathic hypercalciuria and metabolic workup available.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lithiasis patients; Lithiasis patients: diagnosis of recurrent NL confirmed by URO CT with presence of idiopathic hypercalciuria and metabolic workup available.	Other: Data extraction from medical files; 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.	Other: Data extraction from medical files; Data extraction from medical files

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Agnieszka Pozdzik

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2021
• Primary Completion (ACTUAL): June 21, 2022
• Study Completion (ACTUAL): June 21, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (ACTUAL): February 25, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urological Manifestations; Calcium Metabolism Disorders; Calcinosis; Vascular Calcification; Hypercalciuria; Lithiasis
• Other Study ID Numbers: CHUB-Democles

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No