Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
|ClinicalTrials.gov Identifier: NCT00511329|
Recruitment Status : Terminated (PI left the institution)
First Posted : August 3, 2007
Last Update Posted : May 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Juvenile Rheumatoid Crohn Disease||Drug: somatropin [rDNA origin] for injection||Phase 2 Phase 3|
- To determine the effect of GenotropinTM on height, height velocity, body weight and lean body mass. Growth records from previous years will be assessed to determine growth velocity and weight gain. We will measure height and weight during the study using a standardized stadiometer and scale. These parameters will be converted to Z scores (GenenCalcTM, Genentech). Lean body mass (LBM) will be measured by DXA every six months. This specific aim tests the hypothesis that GH significantly improves height, height velocity, weight, weight velocity and LBM in chronically ill children who have grown poorly despite adequate nutritional rehabilitation.
- To determine the effect of GenotropinTM on whole body protein turnover (WBPT), IGF-1 levels and cytokines. Utilizing the stable isotope 1-[13C] leucine, we will measure WBPT. Measurements of WBPT will be correlated with LBM and changes in height and weight velocity. This data will be compared to that from age matched normal children (archival data maintained by the PI). We will measure IGF-1 and the cytokines TNF-α, IL-6 and IL-10 at baseline and very six months. These measures will be correlated with height and weight velocity and IGF-1 levels. Cytokine levels will also be correlated with protein catabolism. This specific aim tests the hypothesis that chronically ill children have increased catabolism, caused by high levels of circulating cytokines and low levels of IGF-1, and that these abnormalities improve with GenotropinTM.
- Evaluation of bone mineral content (BMC) and bone turnover. At baseline and every six months we will measure BMC of the whole body, hip and spine using DXA. Results will be compared to those from age-matched normal children whose results are archived in the body composition laboratory of Dr. Ken Ellis (Children's Nutrition Research Center, Houston). At baseline and every six months we will also measure bone mineral turnover markers including: osteocalcin, bone specific alkaline phosphatase activity, and deoxypyridinoline. All findings will be related to cytokine levels and to use of glucocorticoids. This specific aim tests the hypothesis that bone density is low in chronically ill children secondary to increased osteoclast activity correlating with elevated cytokine levels.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease|
|Study Start Date :||August 2007|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
Drug: somatropin [rDNA origin] for injection
Genotropin will be started at 0.3 mg/kg/week administered by daily subcutaneous injection. Doses will be increased by weight at each visit. Additionally, we will monitor IGF-1 levels at month 3, and 6 and adjust the Genotropin dose to maintain IGF-1 levels in the 50th -75th percentile for ages.
Other Name: Genotropin
- The primary outcome variables will be height and weight Z score. [ Time Frame: 12 months ]
- Secondary outcome variables will include change in lean body mass, change in bone mineral content, change in inflammatory mediated cytokine levels and change in bone turnover. [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511329
|United States, Ohio|
|Columbus Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Dana S Hardin, MD||Nationwide Children's Hospital|