Recruiting NCT07333521

Assessment of Body Composition in Children Treated With Growth Hormone for the Indication of Isolated Non-acquired Growth Hormone Deficiency.

— Observational Isolated Non-acquired Growth Hormone Deficiency

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Auxological measurements and impedancemetry, Auxological measurements and impedancemetry.
Who it may be relevant to: Registry conditions: Isolated Non-acquired Growth Hormone Deficiency. Basic parameters: 3 years — 17 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Since 1985, growth hormone deficiency (GHD) in children has been the first condition treated with daily injections of recombinant human growth hormone. Noncompliance with daily growth hormone (GH) therapy is common. Several long-acting growth hormone (LAGH) treatments have recently become available for prescription in France after pivotal phase III trials demonstrated the non-inferiority of these LAGH compared to daily GH administration. To date, published data on LAGH in children are largely limited to clinical trials of GH deficiency (GHD). Contrary to what is observed with daily GH, body mass index increases during the first year of LAGH treatment. With the Somapacitan, the observed mean body mass index (BMI) (SDS) remained within the normal range, but with an increase from -0.17 to +0.39 in the LAGH group and a decrease from -0.25 to -0.49 in the daily GH group. In the Somatrogon study, BMI increased from -0.51 to -0.08 in the somatrogon group, while it decreased from -0.44 to -0.64 in the daily GH group. This increase in BMI was transient and then normalized over the 3-year follow-up. In June 2025, recent data from the experience of private endocrinologists in France (AFPEL) on the real-life use of somatrogon were presented at the congress of the French Society of Pediatric Endocrinology and Diabetology. They reported a +1 SD increase in BMI during the first months of treatment in a cohort of 99 children, but an improvement was observed after prolonged treatment. However, significant and persistent weight gain was observed in some patients, with a marked increase in abdominal adiposity. Some discontinued LAGH treatment in favor of daily GH. Longer-term, real-life data are therefore needed to better understand the changes in BMI in these children treated with LAGH.

Detailed description

Contrary to what is observed with daily GH, body mass index increases during the first year of LAGH treatment. With the Somapacitan, the observed mean body mass index (BMI) (SDS) remained within the normal range, but with an increase from -0.17 to +0.39 in the LAGH group and a decrease from -0.25 to -0.49 in the daily GH group. In the Somatrogon study, BMI increased from -0.51 to -0.08 in the somatrogon group, while it decreased from -0.44 to -0.64 in the daily GH group. This increase in BMI was transient and then normalized over the 3-year follow-up.

In June 2025, recent data from the experience of private endocrinologists in France (AFPEL) on the real-life use of somatrogon were presented at the congress of the French Society of Pediatric Endocrinology and Diabetology. They reported a +1 SD increase in BMI during the first months of treatment in a cohort of 99 children, but an improvement was observed after prolonged treatment.

However, significant and persistent weight gain was observed in some patients, with a marked increase in abdominal adiposity. Some discontinued LAGH treatment in favor of daily GH.

Longer-term, real-life data are therefore needed to better understand the changes in BMI in these children treated with LAGH.

The study concerns all children in the Department of Pediatric Endocrinology, Gynecology and Diabetology at Necker Enfants Malades University Hospital treated with growth hormone, with the daily form or the delayed form, for the indication of isolated non-acquired growth hormone deficiency, naive to growth hormone treatment or already being treated with growth hormone and wishing to change galenical. Auxological measurements and with the Zmetric impedance meter will be carried out at each visit of the child's usual follow-up, from the day of the start of growth hormone treatment, for 3 years.

Interventions

Other Auxological measurements and impedancemetry
Auxological measurements and with the Zmetric impedance meter will be carried out at each visit of the child's usual follow-up, from the day of the start of growth hormone treatment, for 3 years.
Other Auxological measurements and impedancemetry
Auxological measurements and with the Zmetric impedance meter will be carried out at each visit of the child's usual follow-up, from the day of the change of the galenical of the growth hormone treatment, for 3 years.

Primary outcome measures

Body mass index [Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months]

Secondary outcome measures (6)

Amount of muscle mass [Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months]
Amount of fat mass [Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months]
Bone mineral content [Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months]
Amount of extracellular and intracellular water [Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months]
Hydration of fat-free mass [Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months]
Description of the efficacy and tolerance of growth hormone treatment [Time frame: At the start of treatment or new galenical, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

France · 1 center

Hôpital Necker-Enfants Malades — Paris

Publications

Kopchick JJ, Berryman DE, Puri V, Lee KY, Jorgensen JOL. The effects of growth hormone on adipose tissue: old observations, new mechanisms. Nat Rev Endocrinol. 2020 Mar;16(3):135-146. doi: 10.1038/s41574-019-0280-9. Epub 2019 Nov 28. PMID 31780780
de Fries Jensen L, Antavalis V, Odgaard-Jensen J, Rossi A, Pietropoli A, Hojby M. Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis. Adv Ther. 2024 Nov;41(11):4098-4124. doi: 10.1007/s12325-024-02966-y. Epub 2024 Sep 11. PMID 39261416

Identifiers

NCT: NCT07333521 · APHP251216 · 2025-A01871-48

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗