NCT04484051

Growth Hormone Study in Adults With Prader-Willi Syndrome

Growth Hormone Study in Adults With Prader-Willi Syndroom

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prader-Willi Syndrome

Timeline

• Start date: 2023-03-24
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2020-07-23
• Last updated: 2023-02-16

Locations

1 site across 1 country: Netherlands