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NCT01734486 Clinical Trial

Growth Response in Girls With Turner Syndrome

Turner Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01734486
Other study ID # GHTUR/F/3
Secondary ID
Status Completed
Phase Phase 4
First received November 22, 2012
Last updated February 27, 2017
Start date September 23, 1996
Est. completion date May 21, 2003

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date May 21, 2003
Est. primary completion date May 21, 2003
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
0.9 UI/kg/week. Subcutaneous injection for 3 years
• somatropin
1.8 UI/kg/week. Subcutaneous injection for 3 years

Locations
Country Name City State
France Novo Nordisk Investigational Site Besancon
France Novo Nordisk Investigational Site Bordeaux
France Novo Nordisk Investigational Site Dunkerque
France Novo Nordisk Investigational Site Grenoble
France Novo Nordisk Investigational Site Lille
France Novo Nordisk Investigational Site Lorient
France Novo Nordisk Investigational Site NICE cedex 3
France Novo Nordisk Investigational Site Paris
France Novo Nordisk Investigational Site Reims
France Novo Nordisk Investigational Site Rennes
France Novo Nordisk Investigational Site Rouen
France Novo Nordisk Investigational Site Tarbes
France Novo Nordisk Investigational Site TOULOUSE cedex
France Novo Nordisk Investigational Site Tours
France Novo Nordisk Investigational Site Vandoeuvre Les Nancy

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Height gain, SDS (Standard Deviation Score)
Primary Height gain in cm
Secondary Height
Secondary Bone maturation
See also
  Status Clinical Trial Phase
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Completed NCT01419249 - First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study Phase 4
Completed NCT01518036 - Use of Somatropin in Turner Syndrome Phase 3
Recruiting NCT04948658 - Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Completed NCT01563926 - Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 3
Completed NCT02787486 - Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Completed NCT00877942 - Sex Differences in Early Brain Development; Brain Development in Turner Syndrome N/A
Completed NCT00825617 - Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy N/A
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Enrolling by invitation NCT03836300 - Parent and Infant Inter(X)Action Intervention (PIXI) N/A
Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
Completed NCT01322165 - National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions N/A
Terminated NCT00419107 - Beta Cell Function in Women With Turner Syndrome N/A
Active, not recruiting NCT00625001 - Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome N/A
Completed NCT00029159 - The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome Phase 3
Completed NCT01518062 - Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome Phase 4
Completed NCT00471731 - Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure N/A
Completed NCT00256126 - Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® Phase 4
Completed NCT03181230 - Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome
Completed NCT02160717 - Risk of Diabetes in Young Turner Syndrome Patients N/A

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