Clinical trial NCT00266656: Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
Official title: Effect of Early Growth Hormone Treatment on Long-term Growth and Skeletal Maturation in Girls With Turner Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Turner Syndrome
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-12-19
Enrollment: 69
Sex: FEMALE
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.


Eligibility criteria: Inclusion Criteria:

* Previously randomized in study B9R-US-GDFG (NCT00406926)
* Karyotype-proven Turner syndrome

Exclusion Criteria:

* Immediate family members of study site personnel directly affiliated with the study

Primary outcomes:
measure: Most Mature Height Standard Deviation Score (SDS)
timeFrame: Baseline through End of Study (10 years)
Secondary outcomes:
measure: Height SDS at Various Ages
timeFrame: Age 10, Age 13, Age 16
measure: Age at Attainment of Tanner 2 Breast Development
timeFrame: Baseline through End of Study (10 years)
measure: Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years
timeFrame: Baseline through End of Study (10 years)
measure: Reports of Serious Adverse Events
timeFrame: Baseline through End of Study (10 years)
measure: Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events
timeFrame: Baseline through End of Study (10 years)
measure: Percentage of Participants With Abnormal Tympanometry Results
timeFrame: Baseline, Age 10, Age 16, End of Study (10 years)
measure: Percentage of Participants With Prevalence of Abnormal Audiometry Results
timeFrame: Baseline, Age 10, Age 16, End of Study (10 years)
measure: Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)
timeFrame: Baseline, Age 10, Age 16, End of Study (10 years)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: Aurora
country: United States
facility: Children's Hospital
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Chicago
country: United States
facility: Children's Hospital of Chicago Research Center
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hosptial for Children
state: Indiana
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Chapel Hill
country: United States
facility: University of NC at Chapel Hill School of Medicine
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Seattle
country: United States
facility: Childrens Hospital and Medical Center
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hrs)
role: STUDY_DIRECTOR
References: