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Trial record 1 of 629 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
Enrollment 17
Recruitment Details 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  
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description

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.

Subjects will receive no GH or placebo.
Period Title: Overall Study
Started 11 6
Completed 9 3
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             2             2
Study was ended.             0             1
Arm/Group Title Growth Hormone Control Total
Hide Arm/Group Description

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.

Subjects will receive no GH or placebo. Total of all reporting groups
Overall Number of Baseline Participants 11 6 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 6 participants 17 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 11 participants 6 participants 17 participants
13.12  (0.82) 12.73  (0.50) 12.96  (0.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 6 participants 17 participants
Female
11
 100.0%
6
 100.0%
17
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 6 participants 17 participants
11 6 17
1.Primary Outcome
Title Total Brain Volume
Hide Description Percent change in total brain volume as determined by magnetic resonance imaging (MRI)
Time Frame Change in volume from 12 months of age scan in 24 months of age scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description:
Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
No intervention
Overall Number of Participants Analyzed 5 1
Mean (Standard Deviation)
Unit of Measure: percentage change
18.22  (1.99) 19.78 [1]   (NA)
[1]
N of 1
2.Secondary Outcome
Title Volume of Brain Lobes (Occipital)
Hide Description Percent change in volumes of occipital lobes as determined by MRI.
Time Frame Change in volume from 12 months of age scan in 24 months of age scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description:
Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
No intervention
Overall Number of Participants Analyzed 5 1
Mean (Standard Deviation)
Unit of Measure: percentage change
14.83  (2.21) 12.16 [1]   (NA)
[1]
N = 1
3.Secondary Outcome
Title White Matter Tracts (SLF)
Hide Description Change in the fractional anisotropy (FA) of white matter tracts using Diffusion Tensor Imaging (DTI); superior longitudinal fasciculus
Time Frame Change in FA from 12 months of age scan in 24 months of age scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description:
Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
No intervention
Overall Number of Participants Analyzed 4 1
Mean (Standard Deviation)
Unit of Measure: percentage change
15.12  (5.01) 16.35 [1]   (NA)
[1]
N = 1
4.Secondary Outcome
Title Volume of Brain Lobes (Central)
Hide Description Percent change in volumes of central brain region (precentral gyrus, postcentral gyrus, rolandic operculum) as determined by MRI.
Time Frame Change in volume from 12 months of age scan in 24 months of age scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description:
Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
No intervention
Overall Number of Participants Analyzed 5 1
Mean (Standard Deviation)
Unit of Measure: percentage change
17.63  (2.13) 10.23 [1]   (NA)
[1]
N = 1
5.Secondary Outcome
Title Volume of Brain Lobes (Frontal)
Hide Description Percent change in volumes of frontal lobes as determined by MRI.
Time Frame Change in volume from 12 months of age scan in 24 months of age scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description:
Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
No intervention
Overall Number of Participants Analyzed 5 1
Mean (Standard Deviation)
Unit of Measure: percentage change
15.43  (1.84) 14.38 [1]   (NA)
[1]
N = 1
6.Secondary Outcome
Title Volume of Brain Lobes (Temporal)
Hide Description Percent change in volumes of temporal lobes as determined by MRI.
Time Frame Change in volume from 12 months of age scan in 24 months of age scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description:
Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
No intervention
Overall Number of Participants Analyzed 5 1
Mean (Standard Deviation)
Unit of Measure: percentage change
10.79  (3.68) 5.08 [1]   (NA)
[1]
N = 1
7.Secondary Outcome
Title Volume of Brain Lobes (Parietal)
Hide Description Percent change in volumes of parietal lobes as determined by MRI.
Time Frame Change in volume from 12 months of age scan in 24 months of age scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description:
Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
No intervention
Overall Number of Participants Analyzed 5 1
Mean (Standard Deviation)
Unit of Measure: percentage change
18.86  (5.01) 11.95 [1]   (NA)
[1]
N = 1
8.Secondary Outcome
Title Volume of Brain Lobes (Limbic)
Hide Description Percent change in volumes of parietal lobes as determined by MRI.
Time Frame Change in volume from 12 months of age scan in 24 months of age scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description:
Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
No intervention
Overall Number of Participants Analyzed 5 1
Mean (Standard Deviation)
Unit of Measure: percentage change
15.43  (2.99) 22.71 [1]   (NA)
[1]
N = 1
9.Secondary Outcome
Title Volume of Brain Lobes (Insular Cortex)
Hide Description Percent change in volumes of parietal lobes as determined by MRI.
Time Frame Change in volume from 12 months of age scan in 24 months of age scan
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description:
Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
No intervention
Overall Number of Participants Analyzed 5 1
Mean (Standard Deviation)
Unit of Measure: percentage change
15.79  (2.11) 19.78 [1]   (NA)
[1]
N = 1
Time Frame Baseline and 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Growth Hormone Control
Hide Arm/Group Description

Subjects in the somatotropin (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.

Subjects will receive no GH or placebo.
All-Cause Mortality
Growth Hormone Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Growth Hormone Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Growth Hormone Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/6 (0.00%) 
Low scan success rate and subject drop out resulted in small sample size (5 GH treated, 1 control).
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.
Results Point of Contact
Name/Title: Rebecca Knickmeyer Santelli
Organization: UNC Chapel Hill
Phone: 9199662216
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