Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420251
• Other study ID #: 13042004
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2007
• Last updated: January 9, 2007
• Start date: March 1996
• Est. completion date: July 2006

Study information

• Verified date: January 2007
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis
• Still Disease, Juvenile-Onset

Intervention

Drug:
• Genotropin

Locations

Country	Name	City	State
Germany	Center For Rheumatic Diseases in Childhood	Garmisch Partenkirchen

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Pfizer

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Bechtold S, Ripperger P, Häfner R, Said E, Schwarz HP. Growth hormone improves height in patients with juvenile idiopathic arthritis: 4-year data of a controlled study. J Pediatr. 2003 Oct;143(4):512-9. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final height
Secondary	Bone geometry and density