Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
Information source: Nationwide Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis, Juvenile Rheumatoid; Crohn Disease
Intervention: somatropin [rDNA origin] for injection (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Nationwide Children's Hospital Official(s) and/or principal investigator(s):
Dana S Hardin, MD, Principal Investigator, Affiliation: Nationwide Children's Hospital
Summary
The investigators hypothesize that the anabolic effects of Genotropin (somatropin) will
improve the height and weight of children with inflammatory based chronic illness who have
failed to grow despite receiving adequate nutrition. The investigators will test the
hypothesis by treating 32 chronically ill children (16 JRA and 16 Crohn's) with growth
hormone (GH) for 12 months and comparing them to baseline.
Clinical Details
Official title: Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary outcome variables will be height and weight Z score.
Secondary outcome: 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.
Detailed description:
1. 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.
2. 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.
3. 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.
Eligibility
Minimum age: 5 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Referral for continued poor growth (growth velocity less than the 25th percentile)
2. Height less than the 10th percentile
3. Weight less than the 10th percentile compared to age and gender- matched normal
values.
Exclusion Criteria:
1. Previous diagnosis with diabetes, chronic fevers (temp > 101. 5) or chronic bacterial
infection
2. Previous treatment with GH
3. Bone age > 17
Locations and Contacts
Columbus Children's Hospital, Columbus, Ohio 43205, United States
Additional Information
Related publications: Bechtold S, Ripperger P, Mühlbayer D, Truckenbrodt H, Häfner R, Butenandt O, Schwarz HP. GH therapy in juvenile chronic arthritis: results of a two-year controlled study on growth and bone. J Clin Endocrinol Metab. 2001 Dec;86(12):5737-44. Mauras N, George D, Evans J, Milov D, Abrams S, Rini A, Welch S, Haymond MW. Growth hormone has anabolic effects in glucocorticosteroid-dependent children with inflammatory bowel disease: a pilot study. Metabolism. 2002 Jan;51(1):127-35. Hardin DS, Ellis KJ, Dyson M, Rice J, McConnell R, Seilheimer DK. Growth hormone decreases protein catabolism in children with cystic fibrosis. J Clin Endocrinol Metab. 2001 Sep;86(9):4424-8. Hardin DS, Rice J, Doyle ME, Pavia A. Growth hormone improves protein catabolism and growth in prepubertal children with HIV infection. Clin Endocrinol (Oxf). 2005 Sep;63(3):259-62. Hardin DS, Adams-Huet B, Brown D, Chatfield B, Dyson M, Ferkol T, Howenstine M, Prestidge C, Royce F, Rice J, Seilheimer DK, Steelman J, Shepherds R. Growth hormone treatment improves growth and clinical status in prepubertal children with cystic fibrosis: results of a multicenter randomized controlled trial. J Clin Endocrinol Metab. 2006 Dec;91(12):4925-9. Epub 2006 Oct 3.
Starting date: August 2007
Last updated: May 14, 2015
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