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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06903923
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bone Density
  • Bone Strength
  • GLP - 1
  • Lifestyle Modification
  • Obesity
  • Obesity in Children

Eligibility Criteria

Sex
ALL
Age
12 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • GLP-1 receptor agonist — DRUG
    Participants prescribed a GLP-1 receptor agonist by their physician will be enrolled in this arm of the study. All participants will receive study provided calcium \& vitamin D supplement to support bone health and to reduce this as a confounding factor in overall outcomes
  • Lifestyle intervention — BEHAVIORAL
    Participants receiving usual lifestyle interventions will be enrolled in this arm of the study. All participants will receive study provided calcium \& vitamin D supplement to support bone health and t

Study Details

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

Key Dates

Start date
Jul 31, 2025
Status verified
Apr 2026
Primary completion
Feb 28, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: GLP-1 Receptor Agonist
  • Placebo Comparator: Lifestyle Intervention

Primary Outcome Measure

24-month change in total vBMD at the distal radius [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia Medical CenterCharlottesvilleVirginia22903
Melissa G Gilrain, BS
[email protected]
434-243-6911
[email protected]
Madhusmita Misra, MD, MPH (PRINCIPAL_INVESTIGATOR)
Christine Burt Solorzano, MD (SUB_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Virginia Medical Center· Charlottesville, VA

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