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

This study has been terminated.
(PI left the institution)
Sponsor:
Collaborator:
Pfizer
Information provided by:
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT00511329
First received: August 2, 2007
Last updated: November 18, 2011
Last verified: November 2011
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease

Resource links provided by NLM:


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 ]

Enrollment: 11
Study Start Date: August 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00511329

Locations
United States, Ohio
Columbus Children's Hospital
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:
Responsible Party: Dana S. Hardin, MD, Associate Professor, The Ohio State University, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT00511329     History of Changes
Other Study ID Numbers: GA628132
Study First Received: August 2, 2007
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
growth hormone
short stature
growth failure
chronic illness

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Arthritis, Rheumatoid
Crohn Disease
Autoimmune Diseases
Connective Tissue Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014