Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome

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.

Time frame: Baseline through End of Study (10 years)

Population: All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.

The Tanner 2 breast development is the age at first evidence of breast development.

Time frame: Baseline through End of Study (10 years)

Population: All participants who had a baseline visit and at least one post-baseline visit.

Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years.

Time frame: Baseline through End of Study (10 years)

Population: All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 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.

Time frame: Age 10, Age 13, Age 16

Population: All participants who had a baseline visit and at least one post-baseline visit.

Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL.

Time frame: Baseline, Age 10, Age 16, End of Study (10 years)

Population: All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.

Percentage of participants with abnormal tympanometry \[defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation\] results at baseline, age 10 years, and age 16 years or endpoint.

Time frame: Baseline, Age 10, Age 16, End of Study (10 years)

Population: All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.

Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported.

Time frame: Baseline through End of Study (10 years)

Population: All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.

Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit.

Time frame: Baseline, Age 10, Age 16, End of Study (10 years)

Population: All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.

Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Time frame: Baseline through End of Study (10 years)

Population: All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.