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

Recruitingn/aAges 3 Years - 17 YearsAllAssistance Publique - Hôpitaux de Paris
NCT07333521 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 st

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📋 Eligibility rules (as published)
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.
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What it tests

  • Auxological measurements and impedancemetry
  • Auxological measurements and impedancemetry
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Where

1 site
Hôpital Necker-Enfants Malades
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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