Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents

To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.

Completed

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

15 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males or females : Chronological age > or = 15 years and < or = 20 years for females
Chronological age > or = 17 years and < or = 20 years for males
GHD of childhood onset treated for at least 2 years
Last GH injection at least 12 months before baseline visit

Exclusion criteria

Turner's syndrome
Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN

Treatment and study plan

Blood sample

Procedure

Radiography

Procedure

Primary outcomes

Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial.

Acronym: TAUBER

Important dates

Study start: 2002
Study completion: 2005
First posted: Sep 12, 2005
Registry last updated: Jul 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed