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RECRUITING
NCT06903923
PHASE2

Bone Metabolism in 12-21 Year Olds Undergoing GLP-1 Receptor Agonist Therapy

Sponsor: University of Virginia

View on ClinicalTrials.gov

Summary

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

Official title: Bone Metabolism in Adolescents Undergoing GLP-1 Receptor Agonist Therapy

Key Details

Gender

All

Age Range

12 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-07-31

Completion Date

2030-04-30

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

GLP-1 receptor agonist

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

BEHAVIORAL

Lifestyle intervention

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

Locations (1)

University of Virginia Medical Center

Charlottesville, Virginia, United States