Treatment With Recombinant Human GH in Children With Short Stature Secondary to a Long Term Corticoid Therapy

Condition(s) targeted: Growth Retardation

Intervention: Somatropin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

- to assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy

- to assess the effect of a long term treatment with Genotonorm on bone mineralisation

- to assess the effect of a long term treatment with Genotonorm on body composition

Official title: Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.

Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The main efficacy criteria assess the effects on linear growth of Genotonorm metabolism and body composition.

Secondary outcome:

The other efficacy evaluated criteria are the effect of Genotonorm on bone metabolism and body composition.

The absorptiometry will evaluate the bone mineralisation and the body composition (lean mass, fat mass) at the inclusion visit and every year during 3 years of treatment.

Minimum age: 3 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Children with juvenile arthritis or nephrotic syndrome

- Before or during puberty

Exclusion Criteria:

- Diabetes Type 1 and 2

- Endocrine disease, except well substituted hypothyroidism

Pfizer Investigational Site, Paris 75743, France

Pfizer Investigational Site, Paris 75019, France

To obtain contact information for a study center near you, click here.

Starting date: September 2000
Last updated: August 22, 2007