BELux Children OutcoME During A(@)Dulthood With Growth Hormone Deficiency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Determine the proportion of adult CO-GHD patients who continue to receive regular. medical follow-up
Study Overview
Brief 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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with regular follow-up for their GHD (treated with rhGH or not)
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
Patients who are lost to follow-up or not regularly followed for their GHD (or only followed by their GP with no endocrine assessment)
Intervention: Biological Sample (Other)
Outcomes
Primary Outcomes
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
- Assessment of the regularity of follow-up and compliance with a questionnaire.(Baseline)
- Assessment of the possible comorbidities and health issues with a questionnaire.(Baseline)
- Assessment of the metabolic profile in adulthood.(1 year per patient)
- Describe those data according to treatment adherence.(Baseline)