About this trial
Nephropathic Cystinosis (NC) is an orphan inherited autosomal recessive disease characterised as a generalized lysosomal storage disease due to a deficiency of the cystine lysosomal transport protein, cystinosin.
Patients with NC usually receive cysteamine. Bone impairment was recently recognized as a late complication of NC, occurring at adolescence or early adulthood. Even though the exact underlying pathophysiology is unclear, at least six hypotheses are discussed, and mainly cysteamine toxicity and/or direct bone effect of the Cystinosin (CTNS) mutation. Because of the potential dramatic impact on quality of life of this novel complication, research should aim to better understand bone disease in NC.
The primary objective of this study is to evaluate the action of cysteamine on osteoclastic differentiation and resorption activity of NC patients, depending on the underlying genotype. The Secondary objective is to describe the clinical bone status of NC patients depending on their underlying genotype.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female subjects with confirmed diagnosis of nephropathic cystinosis (defined by clinical signs, White Blood Cells (WBC) cystine level and/or mutation), currently receiving oral cysteamine.
Age > 2 years.
Subjects and/or their parents/ legal guardian must provide non opposition prior to participation in the study.
Disqualifiers
Subjects who, in the opinion of the Investigator, are not able or willing to comply with the protocol.
Trial population
Patients with nephropathic cystinosis (NC)
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood sampling
Other intervention25 mL blood sample will be collected on citrate tubes for osteoclastic analysis.
Treatment groups
Trial outcomes
Primary outcomes
Number of positive Tartrate-resistant acid phosphatase (TRAP) cells
Number of positive TRAP cells will be assessed at the end of osteoclast differentiation from circulating monocytes
Sponsors and contacts
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