Health TrialsbyHealthPanel

Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy

ConditionsObesity in ChildrenBone StrengthGLP - 1Lifestyle ModificationBone DensityObesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-21
SponsorUniversity of Virginia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GLP-1 receptor agonist

    Drug

    Participants prescribed a GLP-1 receptor agonist by their physician will be enrolled in this arm of the study. All participants will receive study provided calcium \& vitamin D supplement to support bone health and to reduce this as a confounding factor in overall outcomes

  • Lifestyle intervention

    Behavioral

    Participants receiving usual lifestyle interventions will be enrolled in this arm of the study. All participants will receive study provided calcium \& vitamin D supplement to support bone health and t

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: GLP-1 Receptor AgonistActive comparator 1 intervention
Group B: Lifestyle InterventionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

24-month change in total vBMD at the distal radius

Using repeated measures analysis, the investigators will compare change in radius vBMD after 24 months of treatment with GLP-1 RAs vs. routine care

Time frame
24 months

Secondary outcomes

1

24-month change in total vBMD at the distal tibia

Using repeated measures analysis, the investigators will compare change in radius vBMD after 24 months of treatment with GLP-1 RAs vs. routine care

Time frame
24 months
2

24-month change in radial and tibial trabecular vBMD

Using repeated measures analysis, the investigators will compare changes in radial and tibial trabecular vBMD after 24 months of treatment with GLP-1 RAs vs. routine care

Time frame
24 months
3

24-month change in total hip and spine areal BMD

Using repeated measures analysis, the investigators will compare changes in areal BMD at the total hip and spine after 24 months of treatment with GLP-1 RAs vs. routine care

Time frame
24 months
4

24-month change in strength estimates (failure load) at the radius and tibia

Using repeated measures analysis, the investigators will compare changes in radial and tibial failure load after 24 months of treatment with GLP-1 RAs vs. routine care

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov
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