Bone Health in Teens and Young Adults Using GLP-1 Receptor Agonists
This study is looking at how a type of medication called GLP-1 receptor agonists (like liraglutide and semaglutide), used for weight loss, affects bone health in young people (ages 12-21) with obesity. Researchers want to see if these medications, compared to lifestyle changes alone, impact bone strength over 24 months. All participants will receive calcium and vitamin D supplements. The study aims to enroll 120 participants. You may be able to join if you are 12-21 years old, have obesity, and are either starting GLP-1 receptor agonist therapy (excluding dulaglutide or exenatide) or are managing your weight with usual lifestyle changes. The main goal is to measure changes in bone density in the wrist after 24 months.
- Study design
- This is an interventional study comparing two groups: one receiving GLP-1 receptor agonists and another focusing on lifestyle changes. It plans to enroll 120 participants.
- What's involved
- You would either take a GLP-1 receptor agonist or continue lifestyle management, take provided calcium and vitamin D supplements, and attend 6 study visits over 24 months, including physical exams, lab work, imaging, questionnaires, and dietary recalls.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months, with the primary endpoint measured at the end of this period.
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NCT06903923
Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy
Recruiting
PHASE2Ages 12–21InterventionalUniversity of VirginiaInvestigator-initiated
~120 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:GLP-1 receptor agonistLifestyle intervention
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
24-month change in total vBMD at the distal radius
Measured over 24 months
Conditions
Where it's being run
1 sites across 1 statesVirginia1
Study leadership
- Madhusmita Misra, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Virginia
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
• Adolescents and young adults with obesity 12-21 years old starting GLP-1 RA therapy (except for dulaglutide or exenatide) or followed with 'usual' care.
Diagnosis of obesity (BMI ≥ 95th percentile for age and sex). The FDA has approved the use of GLP-1 RAs (liraglutide and semaglutide) for adolescents ≥ 12 years old with BMI ≥ 95th percentile for age and sex, and tirzepatide for adults with obesity. Those in the GLP-1 RA arm must have demonstrated efforts at weight loss with 'usual' care, and consistent compliance with appointments and recommendations.
Participants must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of being on medical therapy and implement required behavioral changes
Patients taking orlistat as a precursor to GLP-1 RA therapy due to insurance requirements may be included given minimal effects on weight.
Use of the following contraceptive methods is permitted: Combine oral contraceptives (COCs); continuous oral progestin; Progestin-releasing intrauterine device (IUD); Progestin implant; transdermal patch.
Patients with celiac disease will be included if the condition is well controlled and they are on a gluten free diet with normal 25(OH)D levels confirmed by clinical labs within 3 months of enrollment in the study. If a patient does not have recent 25(OH)D results, we will add this to the screening labs.
Exclusion
• Current or previous history of pregnancy and breast feeding.
Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 if in the GLP-1 RA group.
\> 5 kg weight loss over 3 months given the known impact of significant weight loss on bone density.
Use of dulaglutide and exenatide (of the GLP-1 RAs) given minimal weight loss with these drugs.
Use of medications such as metformin, phentermine, or topiramate that may cause weight loss, or obesogenic antipsychotic medications if treated for \<3 months, or if dosage is not stable for \>2 months.
Medications other than calcium or vitamin D that affect bone, such as systemic glucocorticoids, phenytoin, phenobarbitone (unless there is a washout period of 3 months prior to enrollment if discontinuation is medically permissible)
Female participants on hormonal contraception will be excluded if this involves use of depot medroxyprogesterone acetate (DMPA). DMPA has profound deleterious effect on bone density, which could confound study outcomes related to bone health. Rationale: DMPA has a well-documented deleterious effect on bone density, which could confound study outcomes related to bone health or metabolic parameters.
Untreated thyroid dysfunction or on stable dose for \<3 months. Primary thyroid dysfunction will be defined as: a TSH ≥ 10 IU/L or low per given reference range with unknown thyroid antibody status, or an abnormal TSH if known positive antibodies. Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a normal TSH. For patients with secondary hypothyroidism (deficient production of TSH from the pituitary gland causing hypothyroidism), normal free T4 concentrations (and not TSH alterations) will be used for study inclusion, and recent adjustments in the levothyroxine dose will be permissible as long as free T4 concentrations are in the normal range at dose adjustment (as dose adjustments are often made to get free T4 concentrations in the upper half of the normal range when assessed levels are in the lower half of the normal range). Patients with hyperthyroidism will be excluded given known deleterious effects on both weight and bone metabolism.
Medical conditions known to impact weight or bone density, such as chronic gastrointestinal disorders (including inflammatory bowel disease), other inflammatory conditions, such as rheumatoid arthritis or ankylosing spondylitis, untreated thyroid disease, and hypercortisolemia.
HbA1C \>8% (to avoid deleterious effects on bone from uncontrolled T2DM).
Smoking \>10 cigarettes/day given deleterious effects on bone; substance abuse per DSM-5.
Weight \>450 lbs due to limits for DXA scanners.
History of metabolic and bariatric surgery.
Judged by the investigators to be inappropriate for the study for other reasons not detailed above.
What this trial measures
- 24-month change in total vBMD at the distal radius24 months
Using repeated measures analysis, the investigators will compare change in radius vBMD after 24 months of treatment with GLP-1 RAs vs. routine care