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

NCT06903923 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-17

No results posted yet for this study

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

Conditions

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

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Madhusmita Misra, MD, MPH · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2030-02-28
Completion
2030-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06903923 on ClinicalTrials.gov