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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
  Purpose

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.


Condition Intervention Phase
Turner Syndrome
Drug: Somatropin
Drug: Ethinyl estradiol
Drug: Medroxyprogesterone acetate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Humatrope Treatment to Final Height in Turner's Syndrome

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 154
Study Start Date: February 1989
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
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).
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191113

Locations
Canada, Alberta
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Calgary, Alberta, Canada, T2T 5C7
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Winnipeg, Manitoba, Canada, R3E 0Z2
Canada, Nova Scotia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hamilton, Ontario, Canada, L8S 3Z5
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kingston, Ontario, Canada, K7L 3N6
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, Ontario, Canada, K7L 3N6
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ottawa, Ontario, Canada, K1H 8L1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montreal, Quebec, Canada, H3T 1C5
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montreal, Quebec, Canada, H3H 1P3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sainte-Foy, Quebec, Canada, G1V 4G2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sherbrooke, Quebec, Canada, J1G 2E8
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00191113     History of Changes
Other Study ID Numbers: 817/4419, #817 B9R-CA-GDCT Core study, #4419 GDCT/1 Addenda
Study First Received: September 12, 2005
Results First Received: December 1, 2008
Last Updated: December 13, 2009
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
syndrome
Turner
Turner's
height
growth
growth hormone
somatropin
short stature
short
hearing
glucose metabolism

Additional relevant MeSH terms:
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Syndrome
Turner Syndrome
Adnexal Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Chromosome Disorders
Congenital Abnormalities
Disease
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Ovarian Diseases
Pathologic Processes
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Medroxyprogesterone
Medroxyprogesterone Acetate
Polyestradiol phosphate

ClinicalTrials.gov processed this record on November 20, 2014