BELux Children OutcoME During A(@)Dulthood With GHD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2029-08-01

Brief Summary

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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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Detailed Description

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Conditions

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Growth Hormone Deficiency Adult Growth Hormone Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type ACTIVE_COMPARATOR

Biological Sample

Intervention Type 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.

Interventions

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Biological Sample

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> or = 18 years

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No