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Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents (TAUBER)

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ClinicalTrials.gov Identifier: NCT00156143
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 30, 2007
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Procedure: Blood sample Procedure: Radiography Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : April 2002
Study Completion Date : April 2005





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


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Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156143


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

ClinicalTrials.gov Identifier: NCT00156143     History of Changes
Other Study ID Numbers: 307-MET-9002-016
A6281018
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 30, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases