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

Launched by UNIVERSITY OF VIRGINIA · Mar 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called Semaglutide, which is used to help with weight loss, affects bone health in young people aged 12 to 21 who are living with obesity. Over the course of 24 months, the study will compare the bone health of participants taking Semaglutide to those who are managing their weight through lifestyle changes. All participants will also receive calcium and vitamin D supplements to support their bone health.

To be eligible for the trial, participants need to be between 12 and 21 years old, have a body weight that falls in the obese range, and show that they have been trying to lose weight. During the study, participants will attend six visits where they will have physical exams, lab tests, and dietary assessments. This means they'll be asked about what they eat and will need to drink a special nutritional drink while having their blood tested. It's important to know that this trial isn't currently recruiting participants yet, and there are specific health conditions that may exclude someone from joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adolescents and young adults 12 - 21 years old starting semaglutide therapy or followed by usual care/lifestyle management
• • Diagnosis of obesity (BMI ≥ 95th percentile for age and sex)
• • Participants on semaglutide 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.
• Exclusion Criteria:
• • 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
• • Less than 5 kg weight change over 3 months given the known impact of significant weight loss on bone density
• • Use of medications such as metformin, phentermine, or topiramate that may cause weight loss, or antipsychotic medications that may cause weight gain if treated for \<6 months, or if dosage is not stable for \>2 months
• • Medications other than calcium or vitamin D that affect bone, such as 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 (given its profound deleterious effect on bone density); however, those on combined oral contraceptives, continuous oral progestin, a progestin releasing intrauterine device or implant will not be excluded
• • Untreated thyroid dysfunction or on stable dose for \<3 months
• • 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
• • Judged by the investigators to be inappropriate for the study for other reasons not detailed above.