Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet

Managing bone and mineral disorders associated with chronic kidney disease (CKD-MBD) in children is a complex task. Controlling parathyroid hormone (PTH) levels involves adjusting calcium intake, managing hyperphosphatemia, intensive dialysis, and considering specific therapies like active vitamin D analogues and cinacalcet.

Cinacalcet, authorized in Europe since 2017 for children over 3 undergoing dialysis with secondary hyperparathyroidism (SHPT), has shown efficacy in reducing PTH levels. The 2019 guidelines call for its use with caution particularly to avoid hypocalcemia, in children with severe hyperparathyroidism despite optimized conventional treatments.

In adults, cinacalcet has been found to reduce serum PTH, calcium, and phosphate levels, decrease the risk of vascular calcification, and have a positive effect on bone formation. This suggests that cinacalcet may slow the progression of cardiovascular calcifications.

Additionally, Professor Shroff has introduced a non-invasive method for assessing bone calcium status by analyzing stable calcium isotope ratios in blood. This method would allow to determine whether a treatment such as cinacalcet has a positive influence on bone calcium balance, a key element in the management of CKD-MBD.

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Key information

Conditions

Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Chronic Disease Chronic Kidney Disease-Mineral and Bone Disorder Deficiency Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rickets Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pédiatrie CHU de Bordeaux, Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children from 3 to 17 years of age
On maintenance dialysis : hemodialysis, hemodiafiltration, peritoneal dialysis
Patient who begin treatment with cinacalcet based on the 2019 European guidelines and at the discretion of the treating physician
With normal QTc interval on electrocardiogram
With total serum calcium >2.40 mmol/L
With heamoglobin > 8g/dl
Non - opposition from parents/legal guardians

Exclusion criteria

Children < 12 kg
Persons deprived of their liberty by a judicial or administrative decision
Persons under psychiatric care
Persons admitted to a health or social institution for purposes other than research
Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Persons participating in other interventional research with an exclusion period still in progress at pre-inclusion
Patients who received cinacalcet with 3 months prior inclusion

Treatment and study plan

Supplementary blood samples and urines samples

Biological

Supplementary blood and urines samples realised during routine visits

Primary outcomes

value of isotope ratios of calcium (44/42 Ca) in blood

Time frame: Baseline / 3 months treatment

value of 44/42 Ca ratio in patients at baseline and, three months after cinacalcet treatment

Study contacts

Contact information is provided by the study sponsor or research team.

BACCHETTA Justine, MD

CONTACT

[email protected]

0033427856178

FLAMMIER Sacha, MD

CONTACT

[email protected]

0033472681349

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Calcium Isotope Ratios to Assess Calcium Bone Balance in Dialysis Children Receiving Cinacalcet - The Cin-Ca Study

Acronym: Cin-ca

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 5, 2025
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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