Somatropin Treatment to Final Height in Turner Syndrome (GDCT)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191113
First received: September 12, 2005
Last updated: December 13, 2009
Last verified: December 2009

September 12, 2005
December 13, 2009
February 1989
December 2007   (final data collection date for primary outcome measure)
  • 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 ]
  • To determine the efficacy of somatropin in promoting linear growth to final height in girls with Turner's syndrome who
  • discontinued the previous study and were randomized to the non-treatment control arm of that study,and were active on or after the date
Complete list of historical versions of study NCT00191113 on ClinicalTrials.gov Archive Site
  • 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 ]
No secondary outcomes
Not Provided
Not Provided
 
Somatropin Treatment to Final Height in Turner Syndrome
Humatrope Treatment to Final Height in Turner's Syndrome

A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Turner Syndrome
  • Drug: Somatropin
    0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height).
    Other Names:
    • Humatrope
    • Growth hormone
  • Drug: Ethinyl estradiol
    escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met.
  • Drug: Medroxyprogesterone acetate
    10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.
  • No Intervention: Control
    Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
    Interventions:
    • Drug: Ethinyl estradiol
    • Drug: Medroxyprogesterone acetate
  • Experimental: Humatrope
    Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
    Interventions:
    • Drug: Somatropin
    • Drug: Ethinyl estradiol
    • Drug: Medroxyprogesterone acetate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • girl with Turner syndrome
  • prepubertal, Tanner stage I breast
  • height velocity less than 6 cm/year and height less than or equal to the tenth percentile for sex and age in general population
  • at least 6 months (preferably 12 months) of accurate height measurements available for calculation of pre-study height velocity
  • if thyroxine deficient, to have received replacement therapy, and for six months prior to enrollment have had normal thyroid function tests

Exclusion Criteria:

  • prior treatment with growth hormone
  • presence of a Y component in karyotype with gonads in situ
  • diabetes mellitus
Female
7 Years to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00191113
817/4419, #817 B9R-CA-GDCT Core study, #4419 GDCT/1 Addenda
Yes
Chief Medical Officer, Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP