Growth Hormone DeficiencyBELCOME@GHDNCT06694506
BELux Children OutcoME During A(@)Dulthood With GHD
A study testing Biological Sample in people with Growth Hormone Deficiency and Adult Growth Hormone Deficiency, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Growth Hormone Deficiency, Adult Growth Hormone Deficiency
- What is being tested?
- Biological Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 21 May 2025to 1 May 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, Woluwe-saint-lambert, 1200
Philippe Lysy, Pr, +3227641370, philippe.lysy@saintluc.uclouvain.be
About this study
Official title: BELux Children OutcoME During A(@)Dulthood With Growth Hormone Deficiency
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).
- Being tested
- Biological Sample
- Keywords
- Growth Hormone, Adult
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological SampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with regular follow-up for their GHD (treated with rhGH or not) | No intervention | Patients with regular follow-up for their GHD (treated with rhGH or not) in a adult endocrinology department including a clinical examination and endocrine blood work-up at least once a year |
| Patients who are lost to follow-up or not regularly followed for their GHD | Active comparator | Patients who are lost to follow-up or not regularly followed for their GHD (or only followed by their GP with no endocrine assessment) Receives: Other: Biological Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the proportion of adult CO-GHD patients who continue to receive regular. medical follow-up
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.
Measured: Baseline
Secondary outcomes (4)
Assessment of the regularity of follow-up and compliance with a questionnaire.
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.
Measured: Baseline
Assessment of the possible comorbidities and health issues with a questionnaire.
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.
Measured: Baseline
Assessment of the metabolic profile in adulthood.
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.
Measured: 1 year per patient
Describe those data according to treatment adherence.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start21 May 2025
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We aim to include both male and female adult patients with a diagnosis of childhood onset-GHD, registered in BELGROW, that stopped the GH therapy for growth after 2011 and have a persistent GHD in adolescence/transition period. After completing a questionnaire, each participant will be assigned an analysis group: * Group 1: Patients with regular follow-up for their GHD (treated with rhGH or not) in a adult endocrinology department including a clinical examination and endocrine blood work-up at least once a year * Group 2: Patients who are lost to follow-up or not regularly followed for their GHD (or only followed by their GP with no endocrine assessment)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Lysy, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694506
- Sponsor's protocol ID
- 2024/27AOU/394
- Acronym
- BELCOME@GHD
- Status last verified
- Sep 2026
- First submitted
- 25 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No