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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome

NCTNCT01367834 (opens ClinicalTrials.gov in a new tab)Other id09-2171
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
17 participants (actual)
Sponsor
Rebecca Knickmeyer Santelli, PhD · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
May 2010
Primary completion
May 2014
Completion
May 2014
First posted
7 Jun 2011 (estimated)
Last update posted
24 Mar 2017
Conditions
Turner Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012201320142015
  1. N/A

    Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome

    NCT01367834

    May 2010 to May 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this research study is to learn about brain development in very young girls with Turner syndrome (TS) and the effect that growth hormone (GH) therapy has on early brain development.

Interventions

  • somatotropinDrug

Arms2

  • Experimental

    Growth Hormone

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

  • No intervention

    Control

    Subjects will receive no GH or placebo.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total Brain Volume

    Time frame · Change in volume from 12 months of age scan in 24 months of age scan

    Registry description

    Percent change in total brain volume as determined by magnetic resonance imaging (MRI)

Secondary outcomes(8)

  1. Volume of Brain Lobes (Occipital)

    Time frame · Change in volume from 12 months of age scan in 24 months of age scan

    Registry description

    Percent change in volumes of occipital lobes as determined by MRI.

  2. White Matter Tracts (SLF)

    Time frame · Change in FA from 12 months of age scan in 24 months of age scan

    Registry description

    Change in the fractional anisotropy (FA) of white matter tracts using Diffusion Tensor Imaging (DTI); superior longitudinal fasciculus

  3. Volume of Brain Lobes (Central)

    Time frame · Change in volume from 12 months of age scan in 24 months of age scan

    Registry description

    Percent change in volumes of central brain region (precentral gyrus, postcentral gyrus, rolandic operculum) as determined by MRI.

  4. Volume of Brain Lobes (Frontal)

    Time frame · Change in volume from 12 months of age scan in 24 months of age scan

    Registry description

    Percent change in volumes of frontal lobes as determined by MRI.

  5. Volume of Brain Lobes (Temporal)

    Time frame · Change in volume from 12 months of age scan in 24 months of age scan

    Registry description

    Percent change in volumes of temporal lobes as determined by MRI.

  6. Volume of Brain Lobes (Parietal)

    Time frame · Change in volume from 12 months of age scan in 24 months of age scan

    Registry description

    Percent change in volumes of parietal lobes as determined by MRI.

  7. Volume of Brain Lobes (Limbic)

    Time frame · Change in volume from 12 months of age scan in 24 months of age scan

    Registry description

    Percent change in volumes of parietal lobes as determined by MRI.

  8. Volume of Brain Lobes (Insular Cortex)

    Time frame · Change in volume from 12 months of age scan in 24 months of age scan

    Registry description

    Percent change in volumes of parietal lobes as determined by MRI.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Change in volume from 12 months of age scan in 24 months of age scan

Total Brain Volume

GroupValue (percentage change)Spread
Growth Hormone18.221.99
Control19.78NA
Secondary and other outcome results(7)
Secondary outcomeMean· Change in volume from 12 months of age scan in 24 months of age scan

Volume of Brain Lobes (Occipital)

GroupValue (percentage change)Spread
Growth Hormone14.832.21
Control12.16NA
Secondary outcomeMean· Change in FA from 12 months of age scan in 24 months of age scan

White Matter Tracts (SLF)

GroupValue (percentage change)Spread
Growth Hormone15.125.01
Control16.35NA
Secondary outcomeMean· Change in volume from 12 months of age scan in 24 months of age scan

Volume of Brain Lobes (Central)

GroupValue (percentage change)Spread
Growth Hormone17.632.13
Control10.23NA
Secondary outcomeMean· Change in volume from 12 months of age scan in 24 months of age scan

Volume of Brain Lobes (Frontal)

GroupValue (percentage change)Spread
Growth Hormone15.431.84
Control14.38NA
Secondary outcomeMean· Change in volume from 12 months of age scan in 24 months of age scan

Volume of Brain Lobes (Temporal)

GroupValue (percentage change)Spread
Growth Hormone10.793.68
Control5.08NA
Secondary outcomeMean· Change in volume from 12 months of age scan in 24 months of age scan

Volume of Brain Lobes (Parietal)

GroupValue (percentage change)Spread
Growth Hormone18.865.01
Control11.95NA
Secondary outcomeMean· Change in volume from 12 months of age scan in 24 months of age scan

Volume of Brain Lobes (Limbic)

GroupValue (percentage change)Spread
Growth Hormone15.432.99
Control22.71NA

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Growth HormoneSubjects 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.–0 / 110 / 11
ControlSubjects will receive no GH or placebo.–0 / 60 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 11 Months up to 13 Months
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosis of Turner syndrome * Less than the 50th percentile for length for the general female population Exclusion Criteria: * Prior Growth Hormone (GH) therapy * Diabetes * Allergy to metacresol (a preservative in the GH liquid that is injected) * Contraindications for Magnetic Resonance Imaging (MRI) (such as metal in the body) * Part of a Y chromosome in child's karyotype * Parent/guardian is not willing for child to be randomized to be in the treatment group (receives Growth Hormone injections for one year) or the control group (receives no Growth Hormone during the study) * Parent/guardian is not willing for child to have some of her developmental testing digitally recorded for scoring

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