Effect of Early Growth Hormone Treatment on Long-term Growth and Skeletal Maturation in Girls With Turner Syndrome
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 69
- Locations
- 9
- Primary Endpoint
- Most Mature Height Standard Deviation Score (SDS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 20 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental 1 Control
No drug administration in B9R-US-GDFG (NCT00406926).
Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given.
Intervention: Humatrope (Drug)
Experimental 2 Humatrope
Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given.
Intervention: Humatrope (Drug)
Outcomes
Primary Outcomes
Most Mature Height Standard Deviation Score (SDS)
Time Frame: Baseline through End of Study (10 years)
SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Secondary Outcomes
- Height SDS at Various Ages(Age 10, Age 13, Age 16)
- Age at Attainment of Tanner 2 Breast Development(Baseline through End of Study (10 years))
- Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years(Baseline through End of Study (10 years))
- Reports of Serious Adverse Events(Baseline through End of Study (10 years))
- Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events(Baseline through End of Study (10 years))
- Percentage of Participants With Abnormal Tympanometry Results(Baseline, Age 10, Age 16, End of Study (10 years))
- Percentage of Participants With Prevalence of Abnormal Audiometry Results(Baseline, Age 10, Age 16, End of Study (10 years))
- Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)(Baseline, Age 10, Age 16, End of Study (10 years))