Actively Recruiting
Bone Metabolism in Adolescents and Young Adults With Obesity Undergoing GLP-1 Receptor Agonist Therapy Compared to Lifestyle Intervention
Led by University of Virginia · Updated on 2026-04-17
120
Participants Needed
1
Research Sites
8 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
Researchers are investigating bone health in adolescents and young adults aged 12 to 21 years with obesity who are starting treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs) compared to those with similar weight who follow lifestyle management alone. The study aims to understand whether GLP-1 RA therapy affects bone density, geometry, strength, and bone turnover markers over a 24-month period, as bone health is a concern during weight loss treatments in this age group. This phase 2, non-randomized observational trial is sponsored by the University of Virginia and addresses gaps in knowledge about bone effects of GLP-1RAs in youth compared to adults and surgery outcomes.
CONDITIONS
Brief 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 (BMI 2595th percentile for age and sex) starting GLP-1 receptor agonist therapy (except dulaglutide or exenatide) or followed with usual care
- Demonstrated efforts at weight loss with usual care and consistent compliance with appointments and recommendations for GLP-1 RA group
- Sufficient maturity, psychological stability, and cognitive capacity to understand medical therapy and make behavioral changes
- Patients taking orlistat as a precursor to GLP-1 RA therapy may be included
- Use of approved contraceptive methods including combined oral contraceptives, continuous oral progestin, progestin-releasing IUD, progestin implant, or transdermal patch
- Patients with well-controlled celiac disease on gluten-free diet and normal vitamin D levels confirmed within 3 months
You will not qualify if you...
- Current or previous pregnancy and breastfeeding
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 if in GLP-1 RA group
- Weight loss greater than 5 kg over the past 3 months
- Use of dulaglutide or exenatide GLP-1 RAs
- Use of medications causing weight loss (e.g., metformin, phentermine, topiramate) without stable dosage for over 2 months or obesogenic antipsychotics treated for less than 3 months
- Use of medications affecting bone (other than calcium or vitamin D) like systemic glucocorticoids, phenytoin, phenobarbitone unless washout period of 3 months
- Female participants using depot medroxyprogesterone acetate (DMPA) contraception
- Untreated or unstable thyroid dysfunction including hyperthyroidism
- Medical conditions impacting weight or bone such as inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, untreated thyroid disease, hypercortisolemia
- HbA1c greater than 8%
- Smoking more than 10 cigarettes per day or substance abuse
- Weight over 450 lbs due to DXA scanner limits
- History of metabolic and bariatric surgery
- Any other condition judged inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants either start GLP-1 receptor agonist therapy or continue with lifestyle intervention, both with calcium and vitamin D supplements to support bone health.
Baseline visit before starting therapy, then visits at 6, 12, 18, and 24 months
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
C
Christine Burt Solorzano, MD
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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