Growth Response in Girls With Turner Syndrome

NCT01734486 | Completed Phase 4

• 1 other identifier: GHTUR/F/3
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 15

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.

Conditions

Genetic Disorder; Turner Syndrome

Outcome Measures

Primary Outcomes (2)

• Height gain, SDS (Standard Deviation Score)

• Height gain in cm

Secondary Outcomes (2)

• Height

• Bone maturation

Study Arms (2)

Low dose

EXPERIMENTAL

Drug: somatropin

High dose

EXPERIMENTAL

Drug: somatropin

Interventions

somatropin DRUG

0.9 UI/kg/week. Subcutaneous injection for 3 years

Low dose

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (15)

Novo Nordisk Investigational Site

Besançon, 25030, France

Location

Novo Nordisk Investigational Site

Bordeaux, 33000, France

Location

Novo Nordisk Investigational Site

Dunkirk, 59385, France

Location

Novo Nordisk Investigational Site

Grenoble, 38043, France

Location

Novo Nordisk Investigational Site

Lille, 59037, France

Location

Novo Nordisk Investigational Site

Lorient, France

Location

Novo Nordisk Investigational Site

Nice, 06202, France

Location

Novo Nordisk Investigational Site

Paris, France

Location

Novo Nordisk Investigational Site

Reims, France

Location

Novo Nordisk Investigational Site

Rennes, 35056, France

Location

Novo Nordisk Investigational Site

Rouen, 76031, France

Location

Novo Nordisk Investigational Site

Tarbes, France

Location

Novo Nordisk Investigational Site

Toulouse, 31059, France

Location

Novo Nordisk Investigational Site

Tours, 37044, France

Location

Novo Nordisk Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Genetic Diseases, Inborn; Turner Syndrome

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: November 27, 2012
• Study Start: September 23, 1996
• Primary Completion: May 21, 2003
• Study Completion: May 21, 2003
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

FR (15)