Body composition after daily versus long-acting growth hormone in children
Official title: Assessment of Body Composition in Children Treated With Growth Hormone for the Indication of Isolated Non-acquired Growth Hormone Deficiency.
Run by Assistance Publique - Hôpitaux de Paris · NCT07333521 · Data updated 2026-11-12
See if long-acting versus daily growth hormone changes body weight and body composition in children aged 3–17 with isolated growth hormone deficiency.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 17 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | January 13, 2026 |
| Main results expected | January 13, 2034 |
| Study ends | January 13, 2034 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07333521 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3–17 with confirmed isolated non‑acquired growth hormone deficiency who are growth hormone treatment‑naïve, have BMI ≤ +3 SD, no multiple pituitary insufficiency, no diabetes or known eating disorders, and whose parents and child consent to participate.
✕Probably not a fit
Children with acquired growth hormone deficiency, multiple pituitary hormone deficiencies, pre-existing diabetes, known eating disorders, prior growth hormone treatment, or BMI > +3 SD are excluded and unlikely to benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows treatment‑naïve children aged 3–17 with isolated non‑acquired growth hormone deficiency who are starting either daily or long‑acting growth hormone. Investigators will collect auxological measurements (height, weight, BMI SDS) and body composition by bioelectrical impedance over time to compare early and longer‑term changes. The protocol focuses on the first year when increases in BMI have been reported with long‑acting formulations and will track whether those changes normalize with prolonged treatment. Data are collected during routine care at Hôpital Necker‑Enfants Malades to provide real‑world evidence that complements controlled trials.
Why it matters
Potential benefit: If successful, the results could help doctors choose and monitor growth hormone formulations to limit unwanted changes in weight and body composition.
How similar studies have gone: Phase III trials have shown long‑acting growth hormone preparations are non‑inferior for growth outcomes but have reported early increases in BMI, and real‑world cohorts suggest those BMI increases may be transient and normalize with longer follow‑up.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 3 to 17 years inclusive. * Confirmed diagnosis of growth hormone deficiency. * Indication for treatment with daily or depot growth hormone. * Growth hormone treatment naive or already being treated with growth hormone and wishing to change galenical. * Holders of parental authority and children or adolescents informed and consenting to participate in the study. Exclusion Criteria: * BMI greater than +3 SD. * Multiple pituitary insufficiency. * Acquired growth hormone insufficiency. * Patient with type 1 or type 2 diabetes. * Known eating disorders.
Where it's running
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Hôpital Necker-Enfants Malades
Paris, France Recruiting
Study contacts
- Principal investigator: Michel MD, PhD POLAK, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Michel MD, PhD POLAK, MD, PhD
- Email: michel.polak@aphp.fr
- Phone: 01 44 49 48 02
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.