Clinical trial NCT00396097: Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature
Official title: A Four Year Open Label Multi Center Randomized Two Arm Study Of Genotropin In Idiopathic Short Stature Patients: Comparing An Individualized, Target Driven Treatment Regimen To Standard Dosing Of Genotropin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Short Stature
Keywords: ISS
human growth hormone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 316
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment


Eligibility criteria: Inclusion Criteria:

* Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females
* Naive to Growth Hormone treatment

Exclusion Criteria:

* Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.

Primary outcomes:
measure: Absolute On-target Difference (AOTD) at 24 Months
timeFrame: 2 years
Secondary outcomes:
measure: Variability of Height SDS at 24 Months
timeFrame: 2 years
measure: Time Cost (Months Until >= -2 SDS)
timeFrame: 2 years
measure: Computed Cost of Height Gain at 48 Months
timeFrame: 4 years
measure: Estimated Cost of Height Gain Estimated Until Full Adult Height (FAH) at 48 Months
timeFrame: 4 years
measure: Change From Baseline in Height SDS at 48 Months.
timeFrame: 4 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Alaska
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital - San Diego
state: California
city: San Diego
country: United States
facility: Pediatric Endocrinology of San Diego Medical Group Incorporated
state: California
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Memorial Pediatric Specialty Clinic
state: Colorado
city: Greenwood Village
country: United States
facility: Pediatric Endocrine Associates
state: Colorado
city: Longmont
country: United States
facility: Pediatric Endocrine Associates at The Longmont Clinic
state: Colorado
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital
state: Florida
city: Miami
country: United States
facility: Miller School Of Medicine, University of Miami/Jackson Memorial Medical Center
state: Florida
city: Miami
country: United States
facility: Pediatric Endocrinology Associates
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Tallahassee
country: United States
facility: Nancy Wright, MD
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Children's Hospital
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Pediatric Endocrinology
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center Children's Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: St. Louis
country: United States
facility: Children's Endocrine Care of St. Louis, LLC
state: Missouri
city: Livingston
country: United States
facility: Saint Barnabas Ambulatory Care Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Buffalo
country: United States
facility: Women & Children's Hospital of Buffalo
state: New York
city: Lake Success
country: United States
facility: The Steven and Alexandra Cohen Children's Medical Center of New York (CCMC)
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Sleepy Hollow
country: United States
facility: Diabetes & Endocrine Center for Children & Young Adults at Phelps Memorial Hospital
state: New York
city: Columbus
country: United States
facility: The Research Institute at Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Central Ohio Pediatric Endocrinology/Diabetes Services (COPEDS)
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance, PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: The Endocrine Clinic P.C.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: Ellen Sher, MD PA
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Cooks Children Medical Center/Dept. of Pediatric Endocrinology
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: