Somatropin Treatment to Final Height in Turner Syndrome

Turner Syndrome Clinical Trial

— GDCT  

Official title:

Humatrope Treatment to Final Height in Turner's Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191113
• Other study ID #: 817/4419
• Secondary ID: #817 B9R-CA-GDCT
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 13, 2009
• Start date: February 1989
• Est. completion date: December 2007

Study information

• Verified date: December 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 7 Years to 13 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Intervention

Drug:
• Somatropin
0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height).
• 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.
• Medroxyprogesterone acetate
10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.

Locations

Country	Name	City	State
Canada	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Hamelin CE, Anglin G, Quigley CA, Deal CL. Genomic imprinting in Turner syndrome: effects on response to growth hormone and on risk of sensorineural hearing loss. J Clin Endocrinol Metab. 2006 Aug;91(8):3002-10. Epub 2006 Jun 6. — View Citation

Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27. — View Citation

Lyon AJ, Preece MA, Grant DB. Growth curve for girls with Turner syndrome. Arch Dis Child. 1985 Oct;60(10):932-5. — View Citation

Stephure DK; Canadian Growth Hormone Advisory Committee. Impact of growth hormone supplementation on adult height in turner syndrome: results of the Canadian randomized controlled trial. J Clin Endocrinol Metab. 2005 Jun;90(6):3360-6. Epub 2005 Mar 22. — View Citation

Outcome

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

External Links

•   Lilly Clinical Trial Registry