Identifying Individuals at Risk of Glucocorticoid-Induced Impairment of Bone Disease

Study acronym: RIGID
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Trial completed
    • Study completion date changed from estimate of Apr 2026 to Apr 1, 2026
    • Eligibility criteria expanded, about 14 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2025 to Mar 30, 2026
    • Study completion date: Dec 2025 to Apr 2026
    • Site details revised at 2 of 2 sites
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to Nov 4, 2024
    • Site details revised at 2 of 2 sites
    v3
  4. Start date: May 2024 to Sep 2024v2
  5. 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.
Previous studies have shown that there is a large inter-individual variability in the degree of bone loss during glucocorticoid treatment, and while some patients experience extensive bone loss other patients\' bone mass remains stable. The aim of the study is to find a biomarker that can be used to identify individuals at risk of glucocorticoid-induced bone loss. The study will include 36 healthy volunteers, that will be randomized to receive either glucocorticoid treatment or placebo. During the study blood samples, bone marrow samples, bone tissue samples, and adipose tissue samples are taken and an oral glucose tolerance test is performed.
Trial Details
NCT Number NCT06421597
Lead Sponsor Odense University Hospital
Collaborators: Esbjerg Hospital - University Hospital of Southern Denmark, University of Ulm, University of Birmingham
Conditions
(from sponsor)		 Osteoporosis Secondary
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov