Somatropin Treatment to Final Height in Turner Syndrome (GDCT)

• Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population [ Time Frame: Baseline, and end of 4-year addendum ] [ Designated as safety issue: No ]
  
• Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height [ Time Frame: at completion of core study, or at end of 4-year addendum ] [ Designated as safety issue: No ]
  

• Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population [ Time Frame: every 3 months during core study, and at start and end of 4-year addendum ] [ Designated as safety issue: No ]
  
• Height (Centimeters [cm]) [ Time Frame: every 3 months during core study, and at start and end of 4-year addendum ] [ Designated as safety issue: No ]
  
• Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment [ Time Frame: at completion of core study or beginning of addendum ] [ Designated as safety issue: Yes ]
  
• Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment [ Time Frame: at completion of core study or beginning of addendum ] [ Designated as safety issue: Yes ]
  
• Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment [ Time Frame: at completion of core study or beginning of addendum ] [ Designated as safety issue: Yes ]
  
• Number of Participants With Hearing Loss, Audiologist Assessment [ Time Frame: at completion of core study or beginning of addendum ] [ Designated as safety issue: Yes ]
  
• Fasting Glucose, Change From Baseline [ Time Frame: At core study baseline, and at end of 4-year addendum ] [ Designated as safety issue: Yes ]
  
• Maximum Fasting Glucose Value [ Time Frame: At start and through end of 4-year addendum (up to an additional 2 years) ] [ Designated as safety issue: Yes ]
  
• Number of Participants With Any Abnormal Fasting Glucose Value [ Time Frame: At start and through end of 4-year addendum ] [ Designated as safety issue: Yes ]
  
• Maximum Fasting Insulin Values [ Time Frame: At start and through end of 4-year addendum (up to an additional 2 years) ] [ Designated as safety issue: Yes ]
  
• Number of Participants With Any Abnormal Fasting Insulin Value [ Time Frame: At start and through end of 4-year addendum ] [ Designated as safety issue: Yes ]
  
• Minimum Fasting Glucose/Insulin Ratio Values [ Time Frame: At start and through end of 4-year addendum (up to an additional 2 years) ] [ Designated as safety issue: Yes ]
  
• Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value [ Time Frame: At start and through end of 4-year addendum ] [ Designated as safety issue: Yes ]
  
• Glycosylated Hemoglobin, Change From Baseline [ Time Frame: At core study baseline, and at end of 4-year addendum ] [ Designated as safety issue: Yes ]
  
• Maximum Glycosylated Hemoglobin [ Time Frame: At start and through end of 4-year addendum (up to an additional 2 years) ] [ Designated as safety issue: Yes ]
  
• Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value [ Time Frame: At start and through end of 4-year addendum ] [ Designated as safety issue: Yes ]
  

A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry.

Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome, and to assess the safety of this treatment. Core study completion criteria (protocol final height) are that the patient has both a height velocity < 2 cm per year and a bone age of 14 years or greater.

Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the Control arm of the Core study and who discontinued from the study on or after December 19, 1997.

Addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing, tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in Turner syndrome; 3) to evaluate pancreatic beta cell function (glucose metabolism) in patients previously enrolled in the Core study.

Addendum 3 objective is to determine the parental origin of the retained X chromosome of an appropriate subset of patients currently or previously enrolled in the Core study, and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy.