Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-28 @ 2:45 AM
Study NCT ID:
NCT04484051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-16
First Post:
2020-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth Hormone Study in Adults With Prader-Willi Syndrome
Sponsor:
Erasmus Medical Center
Organization:
Study Overview
Official Title:
Growth Hormone Study in Adults With Prader-Willi Syndroom
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAP
Brief Summary:
The overall objective of this study is to measure the effect of growth hormone (GH) treatment on physical and psychosocial health in adults with Prader-Willi syndrome. Adults with PWS who have not been treated with GH during the past three years and who will start with GH treatment as part of regular patient care will be asked for informed consent to participate in this open-label prospective cohort study. We hypothesize that growth hormone treatment will improve the physical and psychosocial health.
Detailed Description:
OBJECTIVES:
To measure the effect of GHt on physical and psychosocial health in adults with PWS.
The primary endpoint is change in lean body mass (LBM (kg)) as assessed by Dual Energy X-ray Absorptiometry (DEXA) scan. Secondary endpoints are total fat mass, bone density, physical health and psychosocial health. Also the occurrence of side-effects will be assessed. Only data that are collected as part of regular patient care will be used.
STUDY DESIGN:
Open-label prospective cohort study.
STUDY POPULATION:
Adults with PWS who have not been treated with GH during the past three years and who will start with GHt as part of regular patient care.
To measure the effect of GHt on physical and psychosocial health in adults with PWS.
The primary endpoint is change in lean body mass (LBM (kg)) as assessed by Dual Energy X-ray Absorptiometry (DEXA) scan. Secondary endpoints are total fat mass, bone density, physical health and psychosocial health. Also the occurrence of side-effects will be assessed. Only data that are collected as part of regular patient care will be used.
STUDY DESIGN:
Open-label prospective cohort study.
STUDY POPULATION:
Adults with PWS who have not been treated with GH during the past three years and who will start with GHt as part of regular patient care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: