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

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.

Study Overview

• Status: Recruiting
• Conditions: Isolated Non-acquired Growth Hormone Deficiency
• Intervention / Treatment: Other: Auxological measurements and impedancemetry

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Hélène Morel; Phone Number: +33 01 71 19 63 46; Email: helene.morel@aphp.fr
• Study Contact Backup: Name: Michel MD, PhD POLAK, MD, PhD; Phone Number: +33 01 44 49 48 02; Email: michel.polak@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hôpital Necker-Enfants Malades
    • Contact: Michel MD, PhD POLAK, MD, PhD; Phone Number: +33 01 44 49 48 02; Email: michel.polak@aphp.fr
    • Sub-Investigator: Dulanjalee MD KARIYAWASAM, MD
    • Sub-Investigator: Olivier MD POLLE, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Body mass index calculation at each visit of the child's usual follow-up, from the day of the start of growth hormone treatment during 3 years.	At the start of treatment, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of muscle mass	Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment and during 3 years. Amount of muscle mass in kg, in %, in kg/m2.	At the start of treatment, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Amount of fat mass	Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment and during 3 years. Amount of fat mass in kg, in %, in kg/m2.	At the start of treatment, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Bone mineral content	Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment and during 3 years. Bone mineral content in %.	At the start of treatment, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Amount of extracellular and intracellular water	Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment and during 3 years. Amount of extracellular and intracellular water (in L).	At the start of treatment, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Hydration of fat-free mass	Description of the body composition of children treated with GH for the indication of isolated growth hormone deficiency before the start of treatment and during 3 years. Hydration of fat-free mass (in %).	At the start of treatment, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months
Description of the efficacy and tolerance of growth hormone treatment	Description and evolution of health parameters from the patient's usual care during 3 years : Weight, height, waist circumference if over 6 years old, growth rate. Tanner stage.; Blood pressure.; Clinical examination: abnormalities at injection sites, stretch marks, thyroid palpation.; Questionnaire on treatment tolerance: possible adverse events.; IGF-1 levels in ng/ml.; IGF-BP3 levels if available (not routinely measured).; Fasting blood glucose, HbA1c.; TSH, FT4 if available.; Gonadotropin, testosterone/estradiol levels if available.; Lipid profile : investigation of lipid abnormalities, if available.; Liver function tests: AST, ALT, Gamma-GT, bilirubin.	At the start of treatment, 3 months later, at 6 months, 12 months, 18, 24, 30 and 36 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Michel MD, PhD POLAK, MD, PhD, Assistance Publique - Hopitaux de Paris; Study Director: Dinane MD SAMARA-BOUSTANI, MD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Estimated): January 13, 2031
• Study Completion (Estimated): January 13, 2031

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: January 2, 2026
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Body mass index; Impedancemetry; Isolated non-acquired growth hormone deficiency; Daily growth hormone therapy; Long-acting growth hormone treatments; Auxological measurements
• Other Study ID Numbers: APHP251216; 2025-A01871-48 (Other Identifier: ID RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No