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Trial record 1 of 619 for:    "Growth Hormone"
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Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome

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ClinicalTrials.gov Identifier: NCT01367834
Recruitment Status : Completed
First Posted : June 7, 2011
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rebecca Knickmeyer Santelli, PhD, University of North Carolina, Chapel Hill

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Turner Syndrome
Intervention: Drug: somatotropin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited locally in the UNC_Chapel Hill pediatric endocrinology clinic and nationally through the Turner Syndrome Society, Turner Syndrome family internet groups, and advertisements on our UNC research website.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Growth Hormone

Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.

somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life.

Control Subjects will receive no GH or placebo.

Participant Flow:   Overall Study
    Growth Hormone   Control
STARTED   11   6 
COMPLETED   9   3 
NOT COMPLETED   2   3 
Withdrawal by Subject                2                2 
Study was ended.                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Growth Hormone

Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.

somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life.

Control Subjects will receive no GH or placebo.
Total Total of all reporting groups

Baseline Measures
   Growth Hormone   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   6   17 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      11 100.0%      6 100.0%      17 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Months]
Mean (Standard Deviation)
 13.12  (0.82)   12.73  (0.50)   12.96  (0.73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11 100.0%      6 100.0%      17 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   11   6   17 


  Outcome Measures

1.  Primary:   Total Brain Volume   [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]

2.  Secondary:   Volume of Brain Lobes (Occipital)   [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]

3.  Secondary:   White Matter Tracts (SLF)   [ Time Frame: Change in FA from 12 months of age scan in 24 months of age scan ]

4.  Secondary:   Volume of Brain Lobes (Central)   [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]

5.  Secondary:   Volume of Brain Lobes (Frontal)   [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]

6.  Secondary:   Volume of Brain Lobes (Temporal)   [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]

7.  Secondary:   Volume of Brain Lobes (Parietal)   [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]

8.  Secondary:   Volume of Brain Lobes (Limbic)   [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]

9.  Secondary:   Volume of Brain Lobes (Insular Cortex)   [ Time Frame: Change in volume from 12 months of age scan in 24 months of age scan ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Low scan success rate and subject drop out resulted in small sample size (5 GH treated, 1 control).


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rebecca Knickmeyer Santelli
Organization: UNC Chapel Hill
phone: 9199662216
e-mail: rebecca_knickmeyer@med.unc.edu



Responsible Party: Rebecca Knickmeyer Santelli, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01367834     History of Changes
Other Study ID Numbers: 09-2171
First Submitted: June 2, 2011
First Posted: June 7, 2011
Results First Submitted: December 12, 2016
Results First Posted: March 24, 2017
Last Update Posted: March 24, 2017