Growth Response in Girls With Turner Syndrome

February 27, 2017 updated by: Novo Nordisk A/S

Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response

This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25030
        • Novo Nordisk Investigational Site
      • Bordeaux, France, 33000
        • Novo Nordisk Investigational Site
      • Dunkerque, France, 59385
        • Novo Nordisk Investigational Site
      • Grenoble, France, 38043
        • Novo Nordisk Investigational Site
      • Lille, France, 59037
        • Novo Nordisk Investigational Site
      • Lorient, France
        • Novo Nordisk Investigational Site
      • NICE cedex 3, France, 06202
        • Novo Nordisk Investigational Site
      • Paris, France
        • Novo Nordisk Investigational Site
      • Reims, France
        • Novo Nordisk Investigational Site
      • Rennes, France, 35056
        • Novo Nordisk Investigational Site
      • Rouen, France, 76031
        • Novo Nordisk Investigational Site
      • TOULOUSE cedex, France, 31059
        • Novo Nordisk Investigational Site
      • Tarbes, France
        • Novo Nordisk Investigational Site
      • Tours, France, 37044
        • Novo Nordisk Investigational Site
      • Vandoeuvre Les Nancy, France, 54511
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Turner syndrome
  • If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age
  • If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age
  • Measured parental height available
  • Written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose
Drug: somatropin
0.9 UI/kg/week. Subcutaneous injection for 3 years
Drug: somatropin
1.8 UI/kg/week. Subcutaneous injection for 3 years
Experimental: High dose
Drug: somatropin
0.9 UI/kg/week. Subcutaneous injection for 3 years
Drug: somatropin
1.8 UI/kg/week. Subcutaneous injection for 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Height gain, SDS (Standard Deviation Score)
Height gain in cm

Secondary Outcome Measures

Outcome Measure
Height
Bone maturation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 1996

Primary Completion (Actual)

May 21, 2003

Study Completion (Actual)

May 21, 2003

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 22, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHTUR/F/3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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