Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease - Full Text View

Sponsors and Collaborators:	Nationwide Children's Hospital Pfizer
Information provided by:	Nationwide Children's Hospital
ClinicalTrials.gov Identifier:	NCT00511329

Purpose

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.

Condition	Intervention	Phase
Arthritis, Juvenile Rheumatoid Crohn Disease	Drug: somatropin [rDNA origin] for injection	Phase II Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Somatotropin Somatropin Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:

The primary outcome variables will be height and weight Z score. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	5 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Referral for continued poor growth (growth velocity less than the 25th percentile)
Height less than the 10th percentile
Weight less than the 10th percentile compared to age and gender- matched normal values.

Exclusion Criteria:

Previous diagnosis with diabetes, chronic fevers (temp > 101.5) or chronic bacterial infection
Previous treatment with GH
Bone age > 17

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511329

Contacts

Contact: Julie Rice, BSN, RN

614-355-3142

julie.rice@nationwidechildrens.org

Locations

United States, Ohio
Columbus Children's Hospital	Recruiting
Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Nationwide Children's Hospital

Pfizer

Investigators

Principal Investigator:

Dana S Hardin, MD

Nationwide Children's Hospital

More Information

Publications:

Bechtold S, Ripperger P, Muhlbayer D, Truckenbrodt H, Hafner 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.

Responsible Party:	The Ohio State University, Nationwide Children's Hospital ( Dana S. Hardin, MD, Associate Professor )
Study ID Numbers:	GA628132
Study First Received:	August 2, 2007
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00511329
Health Authority:	United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:

growth hormone
short stature
growth failure
chronic illness

Study placed in the following topic categories:

Arthritis, Juvenile Rheumatoid
Autoimmune Diseases
Gastrointestinal Diseases
Joint Diseases
Benzocaine
Arthritis, Rheumatoid
Inflammatory Bowel Diseases
Rheumatic Diseases

Intestinal Diseases
Digestive System Diseases
Musculoskeletal Diseases
Arthritis
Crohn Disease
Connective Tissue Diseases
Chronic Disease
Gastroenteritis

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009