Status:
NOT_YET_RECRUITING
Bone Metabolism in 12-21 Year Olds Undergoing GLP-1 Receptor Agonist Therapy
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Obesity in Children
Bone Strength
Eligibility:
All Genders
12-21 years
Brief 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 (GLP-1) Semaglutide as c...
Detailed Description
Obesity is now epidemic, and as a consequence, the use of weight loss medications and surgery to manage obesity is increasing. Weight loss surgery is associated with significant bone loss, concerning ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2031
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06903923
Start Date
June 1 2025
End Date
June 1 2031
Last Update
April 4 2025
Active Locations (1)
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1
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903