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

Pfizer90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Growth Hormone Deficiency

Interventions

Blood samplePROCEDURE

RadiographyPROCEDURE

Eligibility

Sex: ALLMin age: 15 YearsMax age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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