Chronic Disease Clinical Trial
Official title:
Effects of Growth Hormone on Corticoid Myopathy in Children With Chronic Disease: Effects on Muscle Mass and Strength
Verified date | May 2015 |
Source | Association REMEDE |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2012 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years and older |
Eligibility |
Inclusion Criteria: - Measured Height below -2 SD - Bone age below 13 years for a boy and below 11 years for a girl - Glucocorticosteroid treatment for 12 months at least - Glucocorticosteroid dose above or equal to 0.2 mg/kg/day of prednisone or equivalent dose over the last 12 months - Glucocorticosteroid treatment is anticipated to be sustained for 1 more year at least - The child benefits of the French social security cover - Child who has never been treated by GH. - Evidence of a personally signed and dated informed consent document indicating that the patient's parents/guardians and from the patient himself/herself if he/she is able to receive and understand the information have been informed of all pertinent aspects of the study. - No glucose intolerance or diabetes mellitus on an Oral Glucose Tolerance Test dated less than 3 months Exclusion Criteria: - Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Robert Debré | Paris |
Lead Sponsor | Collaborator |
---|---|
Association REMEDE | Pfizer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main criteria of efficacy will be - the mean strength changes assessed as a composite score (mean of the relative changes of the ten muscle functions tested): ? strength as % of baseline values :6 months-baseline. | 6 months | No | |
Secondary | Strength changes assessed as a composite score (mean of the relative changes of the ten muscle functions tested) as % of baseline values : 12 months-baseline and 12 months- 6 months, 18 months- 6 months for group B patients | 18 months | No |
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