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Registry of Osteogenesis Imperfecta

Study acronym: ROI
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study description expanded, about 62 words
    • Site contact updated
    v9
  2. 4 versions Re-verified since May 24, 2023, no change to tracked fieldsv5-v8
  3. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Study description revisedv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
ROI is a retrospective and prospective registry, finalized for care and research purposes. It is articulated in main sections - strongly related and mutually dependent on each other - corresponding to different data domains: personal information, clinical data, genetic data, genealogical data, surgeries, etc. This approach has been developed to corroborate and integrate data from different sources evaluating several aspects of diseases and to correlate genetic background and phenotypic outcomes, in order to better investigate diseases pathophysiology. Due to legal requirements, institutional directives and organizational issues, we are unable to include individuals residing outside Italy in the registry at this time. We are currently engaged in the preparation of a recruitment process for individuals residing outside Italy.
Trial Details
NCT Number NCT04115774
Lead Sponsor Luca Sangiorgi
Conditions
(from sponsor)		 Osteogenesis Imperfecta
Related terms Osteogenesis Imperfecta
Enrollment 5,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov