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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2031-01-01

Brief Summary

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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.

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Detailed Description

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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.

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. 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.

Conditions

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Isolated Non-acquired Growth Hormone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with isolated non-acquired growth hormone deficiency

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.

Auxological measurements and impedancemetry

Intervention Type OTHER

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

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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.

Intervention Type OTHER

Eligibility Criteria

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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 naïve.- 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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No