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Bone Metabolism in 12-21 Year Olds Undergoing GLP-1 Receptor Agonist Therapy 120 Stile di vita Dieta

In arruolamento
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La sperimentazione clinica NCT06903923 è uno studio osservazionale per Obesity in Children, Bone Strength, GLP - 1, Modifica dello stile di vita, Densità ossea, Obesità, attualmente in arruolamento. Avviato il 31 luglio 2025, prevede di arruolare 120 partecipanti. Sotto la guida di l'Università della Virginia, dovrebbe concludersi entro il 30 aprile 2030. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 31 marzo 2026.
Sommario breve

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 vi...
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Descrizione dettagliata
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 during the adolescent years of peak bone accrual. With the increasing use of weight loss medications, particularly glucagon-like-peptide 1 receptor agonists (GLP-1 RAs), in adolescents, it is essential to determine wheth...Mostra di più
Titolo ufficiale

Bone Metabolism in Adolescents Undergoing GLP-1 Receptor Agonist Therapy

Patologie
Obesity in ChildrenBone StrengthGLP - 1Modifica dello stile di vitaDensità osseaObesità
Altri ID dello studio
Numero NCT
NCT06903923
Data di inizio (effettiva)
2025-07-31
Ultimo aggiornamento pubblicato
2026-03-31
Data di completamento (stimata)
2030-04-30
Arruolamento (previsto)
120
Tipo di studio
Osservazionale
Stato
In arruolamento
Parole chiave
obesity
obesity in children
bone strength
GLP-1
Lifestyle modification
bone density
semaglutide
liraglutide
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
GLP-1 receptor agonist (RA) + Calcium & Vitamin D
The GLP-1 RA, will be prescribed by the participants' physician for routine clinical care for the management of obesity while the Calcium + Vitamin D will be provided by the research investigator.
GLP-1 receptor agonist
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 Management + Calcium & Vitamin D
The Lifestyle Management will be overseen by the participants' physician for routine clinical care for the management of obesity while Calcium + Vitamin D will be provided by the research investigator.
Gestione dello stile di vita
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 to reduce this as a confounding factor in overall outcomes
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Change in total volumetric bone mineral density (vBMD) the distal radius measured by HR-pQCT
To assess the effect of GLP-1 RA therapy on vBMD at a non-weight-bearing site (distal radius) in adolescents and young adults with obesity, compared to matched controls receiving lifestyle management.
24 months
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Change in total volumetric bone mineral density (vBMD) the distal tibia measured by HR-pQCT
24 months
Change in trabecular vBMD of the distal tibia and radius assessed by HR-pQCT
24 months
Change in areal BMD of the lumbar spine and total hip measured by DXA
24 months
Change in estimated bone strength (radius and tibia) using micro finite element analysis (μFEA)
24 months
Change in load-to-strength ratio at the radius and hip
24 months
Change in bone turnover markers (P1NP and CTX)
To assess whether preservation of skeletal integrity is associated with changes in bone formation and resorption markers (P1NP and CTX)
24 months
Change in hormones
Change in hormones known to impact bone (insulin, ghrelin, PYY, oxytocin, estrogens and sclerostin).
24 months
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Bambino, Adulto
Età minima
12 Years
Sessi idonei
Tutti
  • • 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.

  • • 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.
University of Virginia logoUniversità della Virginia294 studi clinici attivi da esplorare
National Institutes of Health (NIH) logoNational Institutes of Health (NIH)
Parte responsabile dello studio
Madhusmita Misra, Investigatore principale, Professor of Pediatrics, University of Virginia
Contatti principali dello studio
Contatto: Madhusmita Misra, MD, MPH, 434-924-9141, [email protected]
Contatto: Christine Burt Solorzano, MD, 434-924-9084, [email protected]
1 Centri dello studio in 1 paesi

Virginia

University of Virginia Medical Center, Charlottesville, Virginia, 22903, United States
Melissa G Gilrain, BS, Contatto, 434-243-6911, [email protected]
Contatto, [email protected]
Madhusmita Misra, MD, MPH, Investigatore principale
Christine Burt Solorzano, MD, Sub-investigatore
In arruolamento