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Trial record 37 of 39 for:    idiopathic intracranial hypertension

Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00266656
Recruitment Status : Completed
First Posted : December 19, 2005
Results First Posted : August 23, 2016
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 15, 2005
First Posted Date  ICMJE December 19, 2005
Results First Submitted Date  ICMJE July 13, 2016
Results First Posted Date  ICMJE August 23, 2016
Last Update Posted Date March 31, 2017
Study Start Date  ICMJE December 2005
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
Most Mature Height Standard Deviation Score (SDS) [ Time Frame: Baseline through End of Study (10 years) ]
SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2005)
Adult height at the end of growth.
Change History Complete list of historical versions of study NCT00266656 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • Height SDS at Various Ages [ Time Frame: Age 10, Age 13, Age 16 ]
    SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
  • Age at Attainment of Tanner 2 Breast Development [ Time Frame: Baseline through End of Study (10 years) ]
    The Tanner 2 breast development is the age at first evidence of breast development.
  • Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years [ Time Frame: Baseline through End of Study (10 years) ]
    Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years.
  • Reports of Serious Adverse Events [ Time Frame: Baseline through End of Study (10 years) ]
    Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
  • Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events [ Time Frame: Baseline through End of Study (10 years) ]
    Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported.
  • Percentage of Participants With Abnormal Tympanometry Results [ Time Frame: Baseline, Age 10, Age 16, End of Study (10 years) ]
    Percentage of participants with abnormal tympanometry [defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation] results at baseline, age 10 years, and age 16 years or endpoint.
  • Percentage of Participants With Prevalence of Abnormal Audiometry Results [ Time Frame: Baseline, Age 10, Age 16, End of Study (10 years) ]
    Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit.
  • Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA) [ Time Frame: Baseline, Age 10, Age 16, End of Study (10 years) ]
    Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2005)
  • Height SDS at various ages.
  • Age at attainment of Tanner 2 breast development.
  • Age at attainment of near-final height.
  • Percentage of subjects for whom serious adverse events are reported.
  • Percentage of subjects for whom certain adverse events are reported.
  • Percentage of subjects with abnormal audiometry results at certain ages.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
Official Title  ICMJE Effect of Early Growth Hormone Treatment on Long-term Growth and Skeletal Maturation in Girls With Turner Syndrome
Brief Summary This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Turner Syndrome
Intervention  ICMJE Drug: Humatrope
According to investigator's clinical practice and guided by the approved package insert
Other Names:
  • LY137998
  • Somatropin
  • Growth hormone
Study Arms  ICMJE
  • Experimental: Experimental 1 Control

    No drug administration in B9R-US-GDFG (NCT00406926).

    Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given.

    Intervention: Drug: Humatrope
  • Experimental: Experimental 2 Humatrope
    Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given.
    Intervention: Drug: Humatrope
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2015)
69
Original Enrollment  ICMJE
 (submitted: December 15, 2005)
88
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously randomized in study B9R-US-GDFG (NCT00406926)
  • Karyotype-proven Turner syndrome

Exclusion Criteria:

  • Immediate family members of study site personnel directly affiliated with the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 4 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00266656
Other Study ID Numbers  ICMJE 10088
B9R-US-GDGH ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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 hrs) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date March 2017

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