Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
Primary Purpose
Arthritis, Juvenile Rheumatoid, Crohn Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
somatropin [rDNA origin] for injection
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid focused on measuring growth hormone, short stature, growth failure, chronic illness
Eligibility 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
Sites / Locations
- Columbus Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Somatropin
Arm Description
Outcomes
Primary Outcome Measures
The Primary Outcome Variables Will be Height and Weight Z Score.
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.
Full Information
NCT ID
NCT00511329
First Posted
August 2, 2007
Last Updated
March 14, 2018
Sponsor
Nationwide Children's Hospital
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00511329
Brief Title
Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
Official Title
Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
PI left the institution
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile Rheumatoid, Crohn Disease
Keywords
growth hormone, short stature, growth failure, chronic illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Somatropin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin [rDNA origin] for injection
Other Intervention Name(s)
Genotropin
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Primary Outcome Variables Will be Height and Weight Z Score.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana S Hardin, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11739431
Citation
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. doi: 10.1210/jcem.86.12.8083.
Results Reference
background
PubMed Identifier
11782884
Citation
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. doi: 10.1053/meta.2002.28972.
Results Reference
background
PubMed Identifier
11549686
Citation
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. doi: 10.1210/jcem.86.9.7822.
Results Reference
background
PubMed Identifier
16117811
Citation
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. doi: 10.1111/j.1365-2265.2005.02331.x.
Results Reference
background
PubMed Identifier
17018651
Citation
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. doi: 10.1210/jc.2006-1101. Epub 2006 Oct 3.
Results Reference
background
Learn more about this trial
Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease
We'll reach out to this number within 24 hrs