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Growth Response in Girls With Turner Syndrome

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ClinicalTrials.gov Identifier: NCT01734486
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Genetic Disorder Turner Syndrome Drug: somatropin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response
Actual Study Start Date : September 23, 1996
Actual Primary Completion Date : May 21, 2003
Actual Study Completion Date : May 21, 2003


Arm Intervention/treatment
Experimental: Low dose Drug: somatropin
0.9 UI/kg/week. Subcutaneous injection for 3 years

Experimental: High dose Drug: somatropin
1.8 UI/kg/week. Subcutaneous injection for 3 years




Primary Outcome Measures :
  1. Height gain, SDS (Standard Deviation Score)
  2. Height gain in cm

Secondary Outcome Measures :
  1. Height
  2. Bone maturation


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734486


Locations
France
Novo Nordisk Investigational Site
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
Tarbes, France
Novo Nordisk Investigational Site
TOULOUSE cedex, France, 31059
Novo Nordisk Investigational Site
Tours, France, 37044
Novo Nordisk Investigational Site
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01734486     History of Changes
Other Study ID Numbers: GHTUR/F/3
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Syndrome
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Genetic Diseases, Inborn
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female