RecruitingPhase 2

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

Bone Metabolism in Adolescents Undergoing GLP-1 Receptor Agonist Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 6 visits
  • Time periods mentioned: 24 months
  • Procedures mentioned: Physical exams, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
  • "Aim 1: To determine to what extent GLP-1 RA therapy alters bone density, geometry, structure, strength and load-to-strength ratio prospectively over 24 months in adolescents and young adults ages 12-21 years with obesity compared to controls of similar weight followed with lifestyle management."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares bone health in people ages 12–21 with obesity who start GLP-1 medicines or use lifestyle changes for weight loss. It lasts 24 months and includes 6 study visits. Participants also take calcium and vitamin D provided by the study.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Ages 12–21 with obesity: a BMI at or above the 95th percentile for age and sex. BMI is a measure of weight compared with height.
  • Starting a GLP-1 medicine, other than dulaglutide or exenatide, or getting usual weight-loss care through lifestyle changes.
  • For the GLP-1 group, have already tried usual weight-loss care and regularly followed appointments and advice.
  • Able to understand the treatment and make the needed behavior changes.
  • May take orlistat before starting a GLP-1 medicine if insurance requires it.
  • May use birth control pills, a hormone-releasing IUD, a hormone implant, or a patch.
  • May have celiac disease if it is well controlled with a gluten-free diet and blood tests show normal vitamin D levels.

Who can't join

  • Current or past pregnancy or breastfeeding. For the GLP-1 group, a personal or family history of medullary thyroid cancer or MEN2, a disorder that causes tumors in hormone-making glands.
  • Lost more than 5 kilograms (about 11 pounds) in 3 months, weigh over 450 pounds, or have had weight-loss surgery.
  • Use dulaglutide or exenatide. Certain weight-loss medicines or antipsychotic medicines that cause weight gain may also rule you out if used for less than 3 months or if the dose has not been stable for over 2 months.
  • Use medicines that affect bones, other than calcium or vitamin D, unless safely stopped at least 3 months before joining. Use the DMPA birth control shot.
  • Have an overactive thyroid, untreated thyroid problems, or thyroid treatment that does not meet study rules. Some people with treated low thyroid hormone may qualify.
  • Have another condition that affects weight or bone strength, such as long-term gut disease, certain joint diseases, or too much cortisol, a hormone.
  • Have an HbA1c above 8%, a blood test showing high average blood sugar. Smoke more than 10 cigarettes a day or meet the study's rules for substance abuse.
  • The study team finds another reason that makes the study unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * • 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 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. * \> 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.

Study sites (1)

VA