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NCT Number: NCT06694506

BELux Children OutcoME During A(@)Dulthood With GHD

Our objective is to evaluate the outcome in adulthood of Belgian and Luxembourgish patients treated with rhGH during childhood for CO-GHD. The primary goal is to determine the proportion of adult CO-GHD patients who continue to receive regular medical follow-up and those still undergoing rhGH therapy using a questionnaire. Secondary objectives include assessing the regularity of follow-up and compliance with treatment in adulthood, evaluating possible comorbidities, health issues, lifestyle, living environment, and quality of life. Additionally, we aim to assess the metabolic profile in adulthood, particularly focusing on BMI, glycemic, and lipid data, for patients who consent to share their current clinical and biological data. Data will be described according to treatment adherence and CO-GHD etiology/phenotypes (e.g., idiopathic vs. organic GHD, isolated vs. combined GHD, partial vs. severe GHD).

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Key information

Conditions

Growth Hormone Deficiency Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Brussels, Woluwe-saint-lambert, 1200, Belgium

Location contact

Philippe Lysy, Pr

CONTACT

[email protected]

+3227641370

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > or = 18 years
  • Diagnosed with child-hood onset growth hormone deficiency (CO-GHD) (no exclusion criteria: isolated or multiple GHD, idiopathic or organic, severe or partial)
  • Registered in the BELGROW registry (informed consent at the time of inclusion in registry)
  • Stopped treatment with rhGH for growth after 2011
  • Persistent GHD at the end of growth

Exclusion criteria

  • No exclusion criteria

Treatment and study plan

Biological sample

Other

Clinical examination and blood test. The clinical examination and blood test are considered standard-of-care as they could be performed annually or bi-annually as part of an adult GHD follow-up. Subsequently, the data will be collected directly from the patient's chosen physician.

Primary outcomes

  1. Determine the proportion of adult CO-GHD patients who continue to receive regular. medical follow-up

    Time frame: Baseline

    Using our questionnaire, the primary objective is to determine the proportion of adult CO-GHD patients who continue to receive regular medical follow-up (and where/by who) and the proportion of patients still undergoing rhGH therapy.

Secondary outcomes

  1. Assessment of the regularity of follow-up and compliance with a questionnaire.

    Time frame: Baseline

    Assessment of the regularity of follow-up and compliance to treatment in adulthood (in patients that are still followed and/or treated with rhGH therapy), with the help of a questionnaire created by the research team.

  2. Assessment of the possible comorbidities and health issues with a questionnaire.

    Time frame: Baseline

    Assessment of the possible comorbidities and health issues, lifestyle, living environment and quality of live (all patients) in adulthood. with the help of a questionnaire created by the research team.

  3. Assessment of the metabolic profile in adulthood.

    Time frame: 1 year per patient

    Assessment of the metabolic profile in adulthood - particularly in relation to BMI, glycemic and lipid data. (fasting glycemia, fasting insulin, hemoglobin A1c, transaminase levels, lipid profile (total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides), insulin-like growth factor 1 (IGF-1) levels, and other hormone levels (thyroid-stimulating hormone (TSH), thyroxine (T4), prolactin (PRL), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol/testosterone, cortisol).). Each of these data will be compared with the clinical data in the same way.

  4. Describe those data according to treatment adherence.

    Time frame: Baseline

    Describe those data according to treatment adherence and CO- GHD etiology/phenotypes (e.g. idiopathic vs organic GHD, isolated vs combined GHD, partial vs severe GHD) The questionnaire will provide us with information on patients' adherence to treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Laure Boutsen, MD

CONTACT

[email protected]

02 7641933 ext. +32

Philippe Lysy, MD, PhD

CONTACT

[email protected]

02 7641370 ext. +32

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

BELux Children OutcoME During A(@)Dulthood With Growth Hormone Deficiency

Acronym: BELCOME@GHD

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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