Somatropin Treatment to Final Height in Turner Syndrome (GDCT)

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ClinicalTrials.gov Identifier: NCT00191113

Recruitment Status : Completed

First Posted : September 19, 2005

Results First Posted : January 27, 2010

Last Update Posted : January 27, 2010

Sponsor:

Information provided by:

Eli Lilly and Company

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Turner Syndrome	Drug: Somatropin Drug: Ethinyl estradiol Drug: Medroxyprogesterone acetate	Phase 3

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	154 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Humatrope Treatment to Final Height in Turner's Syndrome
Study Start Date :	February 1989
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Turner syndrome

MedlinePlus related topics: Primary Ovarian Insufficiency Turner Syndrome

Drug Information available for: Somatotropin Somatropin Serostim

Genetic and Rare Diseases Information Center resources: Gonadal Dysgenesis Turner Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Arm

Intervention/treatment

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.

Outcome Measures

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 ]
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 ]

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 ]
Height (Centimeters [cm]) [ Time Frame: every 3 months during core study, and at start and end of 4-year addendum ]
Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment [ Time Frame: at completion of core study or beginning of addendum ]
Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment [ Time Frame: at completion of core study or beginning of addendum ]
Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment [ Time Frame: at completion of core study or beginning of addendum ]
Number of Participants With Hearing Loss, Audiologist Assessment [ Time Frame: at completion of core study or beginning of addendum ]
Fasting Glucose, Change From Baseline [ Time Frame: At core study baseline, and at end of 4-year addendum ]
Maximum Fasting Glucose Value [ Time Frame: At start and through end of 4-year addendum (up to an additional 2 years) ]
Number of Participants With Any Abnormal Fasting Glucose Value [ Time Frame: At start and through end of 4-year addendum ]
Maximum Fasting Insulin Values [ Time Frame: At start and through end of 4-year addendum (up to an additional 2 years) ]
Number of Participants With Any Abnormal Fasting Insulin Value [ Time Frame: At start and through end of 4-year addendum ]
Minimum Fasting Glucose/Insulin Ratio Values [ Time Frame: At start and through end of 4-year addendum (up to an additional 2 years) ]
Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value [ Time Frame: At start and through end of 4-year addendum ]
Glycosylated Hemoglobin, Change From Baseline [ Time Frame: At core study baseline, and at end of 4-year addendum ]
Maximum Glycosylated Hemoglobin [ Time Frame: At start and through end of 4-year addendum (up to an additional 2 years) ]
Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value [ Time Frame: At start and through end of 4-year addendum ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	7 Years to 13 Years (Child)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 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.
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.
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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Publications of Results:

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.

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.

Other Publications:

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Taback SP, Van Vliet G. Health-related quality of life of young adults with Turner syndrome following a long-term randomized controlled trial of recombinant human growth hormone. BMC Pediatr. 2011 May 29;11:49. doi: 10.1186/1471-2431-11-49.


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
First Posted:	September 19, 2005 Key Record Dates
Results First Posted:	January 27, 2010
Last Update Posted:	January 27, 2010
Last Verified:	December 2009

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:


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

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