Actively Recruiting
Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy
Led by University of Virginia · Updated on 2026-04-17
120
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents and young adults aged 12 to 21 years with obesity starting GLP-1 RA therapy (except dulaglutide or exenatide) or followed with usual care
- Diagnosis of obesity with BMI at or above the 95th percentile for age and sex
- Must have made efforts at weight loss with usual care and show consistent compliance with appointments and recommendations (for GLP-1 RA group)
- Demonstrated sufficient maturity, psychological stability, and cognitive ability to understand medical therapy and implement behavioral changes
- Patients taking orlistat as a precursor to GLP-1 RA therapy may be included
- Use of certain contraceptive methods allowed: combined oral contraceptives, continuous oral progestin, progestin-releasing IUD, progestin implant, transdermal patch
- Patients with well-controlled celiac disease on a gluten-free diet with normal 25(OH)D levels confirmed within 3 months
You will not qualify if you...
- Current or previous pregnancy or breastfeeding
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (for GLP-1 RA group)
- Weight loss greater than 5 kg in the past 3 months
- Use of dulaglutide or exenatide
- Use of weight-loss medications like metformin, phentermine, or topiramate if treated less than 3 months or unstable dosage
- Use of medications affecting bone other than calcium or vitamin D, such as systemic glucocorticoids, phenytoin, phenobarbitone without a 3-month washout
- Female participants using depot medroxyprogesterone acetate (DMPA) contraception
- Untreated thyroid dysfunction or thyroid treatment less than 3 months
- Medical conditions affecting weight or bone density, including chronic gastrointestinal disorders, inflammatory diseases, untreated thyroid disease, hypercortisolemia
- HbA1C greater than 8%
- Smoking more than 10 cigarettes per day or substance abuse
- Weight over 450 lbs due to scanner limits
- History of metabolic and bariatric surgery
- Any other reasons judged by investigators as inappropriate for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
M
Madhusmita Misra, MD, MPH
CONTACT
C
Christine Burt Solorzano, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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