FindTrial
Sign In

Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWS

Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004716-31-NL
Enrollment
Unknown
Registered
2007-11-06
Start date
2008-03-05
Completion date
Unknown
Last updated
2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prader-Willi Syndrome MedDRA version: 9.1 Level: LLT Classification code 10036476 Term: Prader-Willi syndrome

Interventions

Trade Name: Genotropin Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use

Sponsors

Dutch Growth Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Genetically confirmed diagnosis of PWS and -treated with GH during childhood for at least 2 years and -final height is reached or epiphysial fusion is complete and -aged 18-24 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -non cooperative behaviour -extremely low dietary intake of less than minimal required intake according to WHO -medication to reduce weight (fat)

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess effects of GH-treatment versus placebo in young adults with Prader-Willi Syndrome after reaching final height on - body composition - carbohydrate metabolism - psychosocial functioning - sleep-related breathing disorders - circulating lipids - blood pressure ;Secondary Objective: - To study the effects of GH-treatment versus placebo in young adults with Prader-Willi Syndrome after reaching final height on thyroid hormone levels, IGF-I and IGF binding proteins, adiponectin, ghrelin. - To study compliance to the diet. ;Primary end point(s): The aim of this double-blind cross-over, placebo-controlled study is to evaluate effects of GH-treatment versus withdrawal of GH, after final height is reached, on weight, body composition (as measured with DXA), psychosocial functioning (as measured with GIT, behavioural questionnaires), carbohydrate metabolism (as measured with OGTT), circulating lipids (total cholesterol, HDL, LDL, Lipoprotein A, TG), and sleep-related breathing (polysomnography) during transition period until the age of 24 years.—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026