Chronic Disease Clinical Trial
Official title:
Effects of Growth Hormone on Corticoid Myopathy in Children With Chronic Disease: Effects on Muscle Mass and Strength
Children suffering from chronic disease and receiving long-term glucocorticoid therapy
suffer over years from severe growth retardation and profoundly altered body composition.
They consist in a marked increase in fat mass and a decrease in lean body mass. Published
studies have shown that Growth Hormone (GH) treatment in children with Juvenile Idiopathic
Arthritis can improve body composition by increasing lean mass and by preventing increase in
fat mass. The aim of the present protocol is to evaluate whether the increase in lean body
mass observed during GH treatment is associated with changes in muscle strength and mass.
In order to be able to evaluate the effect of GH on the muscle a comparative group is
needed. Therefore it will be proposed to delay in a group of patients the start of Growth
Hormone(GH) treatment by 6 months. As most publications have shown a maximum effect of GH
within the first year of treatment, six months should be enough to evaluate short-term
effect of GH on the muscle. Therefore, this study will be a randomized trial: immediate
start of Growth Hormone (GH) treatment versus start of Growth Hormone treatment 6 months
later. After 6 months all children will be treated with GH. Therefore, the follow-up will be
one year after baseline.
The aim of the present protocol is to evaluate the effects of GH treatment in long-term
steroid treated children, on muscle mass, and muscle strength. It will be an open,
randomized, controlled, 2-parallel group study. The follow-up in this study will be one
year. The objective of this study will be to evaluate short-term effects of GH treatment on
muscle mass, muscle strength and body composition in children suffering from various
diseases requiring steroid therapy. Expected pathologies are juvenile idiopathic arthritis,
nephrotic syndrome, uveitis, systemic diseases and organ transplantation. Changes in muscle
mass will be assessed by measuring the muscle and sub-cutaneous fat on the cross sectional
area of the thigh by MRI. MRI offer the advantage of non-invasive technique, allowing serial
and accurate measurements.Muscle strength will be performed by serial muscular testing of
different muscular groups. Body composition will be assessed by DEXA. DEXA allows rapid,
accurate and highly reproductible determination not only of bone mass but also of lean and
fat mass of the whole body, with very low radiation exposure.It appears to be the most
sensitive method for assessment of muscle wasting as well as of fat repartition that
contribute to Cushing's appearance in steroid treated patients.
The present study will be performed in children with growth retardation related to long-term
glucocorticoid treatment These patients had never been treated with GH. In order to be able
to evaluate the effect of GH on the muscle a comparative group is needed. Therefore it will
be proposed in the study to delay in a group of patient the start of GH treatment by 6
months. Six months should be enough to evaluate short-term effect of GH on the muscle and
most publication have shown a maximum effect of GH within the first year of treatment.
Therefore, this study will be a randomized trial: immediate start of GH treatment versus
start of GH treatment 6 months later. After 6 months all children will be treated with GH.
The dose administered in the present trial will be a GH dose already tested in
glucocorticoid treated children (0.46 mg/kg/week)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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