Recombinant Human Growth Hormone Treatment in Juvenile Idiopathic Arthritis: Controlled Study on the Effect on Growth and Bone Development

Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

Sponsors

Lead sponsor: Ludwig-Maximilians - University of Munich

Collaborator: Pfizer

Source Ludwig-Maximilians - University of Munich
Brief Summary

Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. Additionally, we are interested in bone density development in those treated with growth hormone.

Detailed Description

Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. This is the case in patients with a polyarticular and a systemic form of juvenile idiopathic arthritis. The permanent consequence is short stature at final height. Up to 30% of these patients will have a final height below the 3rd percentile, even after discontinuation of glucocorticoid treatment. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. From safety aspects we were interested in the effect of growth hormone on the disease activity. Additionally, we are interested in bone density development in those treated with growth hormone up to final height.

Overall Status Completed
Start Date March 1996
Completion Date July 2006
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Final height
Secondary Outcome
Measure Time Frame
Bone geometry and density
Enrollment 50
Condition
Intervention

Intervention type: Drug

Intervention name: Genotropin

Eligibility

Criteria:

Inclusion Criteria:

- Polyarticular or systemic juvenile idiopathic arthritis,

- Growth velocity below the 25th percentile and or short stature ,

- Treatment with glucocorticoids for at least the previous 6 months before inclusion,

- Prepubertal stage,

- Bone age below 10 in girls and 12 in boys,

- Growth hormone levels after stimulation with clonidine or arginine above 10 ng/ml

Exclusion Criteria:

- Previous treatment with growth hormone,

- Endocrinopathy,

- Additional chronic disease beside juvenile idiopathic arthritis,

- Malignant disase,

- Chromosomal aberration or othe syndromal disease,

- Previous treatment with Oxandrolone,

- Small for gestational age,

- Elevated fasting glucose level

Gender: All

Minimum age: 4 Years

Maximum age: 14 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Susanne M Bechtold, MD Principal Investigator University Children´s Hospital, Munich
Location
facility
Center For Rheumatic Diseases in Childhood
Location Countries

Germany

Verification Date

January 2007

Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov