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Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary endpoint(s) modified
    • Secondary endpoints revised (7)
    • Study description expanded, about 1 word
    • Study title expanded, about 3 words
    v6
  2. Phase changed: not specified → Phase 2
    • Primary completion moved earlier from Jun 1, 2030 to Feb 28, 2030
    • Study completion moved earlier from Jun 1, 2031 to Apr 30, 2030
    • Interventions: GLP-1 receptor agonist (Drug), Lifestyle Management (Behavioral) to GLP-1 receptor agonist (Drug), Lifestyle intervention (Behavioral)
    v5
  3. Start date: Jun 1, 2025 to Jul 31, 2025v4 Show 6 more changesShow less
    • Primary completion date: Jun 1, 2030 to Feb 28, 2030
    • Study completion date: Jun 1, 2031 to Apr 30, 2030
    • Eligibility criteria expanded, about 320 words
    • Secondary endpoints revised (7)
    • Study description shortened, about 25 words
    • Site contact updated
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  5. Primary endpoints: 5 to 1
    • Eligibility criteria shortened, about 52 words
    • Secondary endpoints: 1 to 7
    • Study description expanded, about 778 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
University of Virginia
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Obesity
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The goal of this clinical trial is to compare bone health markers over 24 months in participants 12 - 21 years of age with obesity who are starting the glucagon-like peptide-1 receptor agonists (GLP-1RAs) as compared to those with similar weight followed by lifestyle management. Participants will: * Take GLP-1RA as prescribed or continue to work on lifestyle management for weight loss * Take provided calcium and vitamin D supplements * Attend 6 study visits over 24 months with two at the beginning and then every 6 months that include: * History and Physical Exams * Lab Work * Imaging studies * Questionnaires * 24-hour dietary recalls
Trial Details
NCT Number NCT06903923
Lead Sponsor University of Virginia
Collaborators: National Institutes of Health (NIH)
Conditions
(from sponsor)		 Obesity in Children, Bone Strength, GLP - 1, Lifestyle Modification, Bone Density, Obesity
Related terms Obesity, Pediatric Obesity
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov