CYSTEA-BONE Clinical Study

Study acronym: CYSTEA-BONE
StatusUnknown
PhaseNot specified
Started

Record status This record was last updated March 3, 2025 (before its estimated October 5, 2026 completion). Its status may not reflect the trial's current state.

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Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Feb 2024); last known: Recruiting
  2. Notable Primary and study completion dates: Oct 5, 2024 to Oct 5, 2026v7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Notable Primary and study completion dates: Oct 5, 2022 to Oct 5, 2024v5
  5. Notable Primary and study completion dates: Oct 5, 2020 to Oct 5, 2022v4
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  1. Minor Study sites: 10 to 13v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Nov 1, 2020 to Oct 5, 2020
    • Start date changed from estimate of Jun 1, 2019 to Apr 5, 2019
    • Site details revised at 10 of 10 sites
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03919981
Lead Sponsor Hospices Civils de Lyon
Conditions
(from sponsor)
Nephropathic Cystinosis
Related terms Cystinosis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov