CYSTEA-BONE Clinical Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorHospices Civils de Lyon

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling

    Other intervention

    25 mL blood sample will be collected on citrate tubes for osteoclastic analysis.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: nephropathic cystinosis patients receiving cysteamine1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 day

Secondary outcomes

Other outcomes

Sponsors and contacts

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