Efficacy and Safety of Growth Hormone Treatment in Juveni... | NCT00420251

Studies
Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

NCT00420251

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Jan 11, 2007Estimated

Enrollment

Phase

Phase 3

Conditions

Juvenile Idiopathic Arthritis
Still Disease, Juvenile-Onset

Interventions

Genotropin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1996

Primary Completion Date

Not provided

Completion Date

Jul 2006

First Submitted Date

Jan 9, 2007

First Submission Date that Met QC Criteria

Jan 9, 2007

First Posted Date

Jan 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2007

Last Update Posted Date

Jan 11, 2007Estimated

Name	Class
Pfizer	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Genotropin	Drug

Measure	Description	Time Frame
Final height

Measure	Description	Time Frame
Bone geometry and density

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susanne M Bechtold, MD	University Children´s Hospital, Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center For Rheumatic Diseases in Childhood		Garmisch-Partenkirchen		82152	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11739431	Result	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.
14571231	Result	Bechtold S, Ripperger P, Hafner 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. doi: 10.1067/S0022-3476(03)00390-1.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones