Clinical trial NCT00262249: Effect of Growth Hormone in Children With Growth Hormone Deficiency
Official title: Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Growth Disorder
Idiopathic Short Stature
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-12-06
Enrollment: 173
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.


Eligibility criteria: Inclusion Criteria:

* Clinically suspected GHD
* Height \< -2.0 SDS
* Serum IGF-I less than or equal to -1.0 SDS
* Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls.
* Puberty Tanner Stage I

Exclusion Criteria:

* Previous use of growth hormone
* Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.)
* Intrauterine growth retardation: birth weight \< 3rd percentile.
* Administration of other growth-altering medications.
* Evidence of any malignancy or intracranial tumors.

Primary outcomes:
measure: Change in height standard deviation score
timeFrame: 24 month
Secondary outcomes:
measure: IGF-I
measure: IGFBP-3
measure: free IGF-I
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Sacramento
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Stanford
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: New Haven
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Gainesville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Skokie
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Shreveport
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Springfield
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Morristown
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Buffalo
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Hershey
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Seattle
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Cohen P, Rogol AD, Howard CP, Bright GM, Kappelgaard AM, Rosenfeld RG; American Norditropin Study Group. Insulin growth factor-based dosing of growth hormone therapy in children: a randomized, controlled study. J Clin Endocrinol Metab. 2007 Jul;92(7):2480-6. doi: 10.1210/jc.2007-0204. Epub 2007 Mar 13.