NCT01518062

Brief Summary

This trial is conducted in Europe. The aim of this trial is to assess whether increasing doses of somatropin (Norditropin®) can maintain the initial increase in height velocity and improve final height. This trial has two trial periods, a main period of 4 years and an extension period until final height is reached.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 1989

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1989

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

13.8 years

First QC Date

January 20, 2012

Last Update Submit

January 17, 2017

Conditions

Genetic DisorderTurner Syndrome

Outcome Measures

Primary Outcomes (1)

  • Final height

Secondary Outcomes (4)

  • Height velocity (cm/year)

  • Ratio between change in bone age and change in chronological age

  • Age at onset of puberty

  • Adverse events

Study Arms (3)

Low dose

EXPERIMENTAL
Drug: somatropinDrug: oestrogen

Medium dose

EXPERIMENTAL
Drug: somatropinDrug: oestrogen

High dose

EXPERIMENTAL
Drug: somatropinDrug: oestrogen

Interventions

somatropinDRUG

4 IU/m\^2 body surface for 4 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection

Low dose
oestrogenDRUG

Treatment with oestrogen was administered if spontaneous puberty had not occurred by age 12 years and was initiated in the extension period after at least four years of somatropin treatment

High doseLow doseMedium dose

Eligibility Criteria

Age2 Years - 11 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Turner Syndrome
  • Well documented growth rate during the previous year
  • Height below the 50th percentile for the age in Dutch children
  • Normal thyroid function

You may not qualify if:

  • Any endocrine or metabolic disorder
  • Growth failure due to disorders of genitourinary, cardio-pulmonary, gastro-intestinal and nervous systems, nutritional/vitamins deficiencies and chondrodysplasias
  • Patients with hydrocephalus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Alphen aan den Rijn, Netherlands

Location

Related Publications (7)

  • van Teunenbroek A, de Muinck Keizer-Schrama SM, Stijnen T, Jansen M, Otten BJ, Delemarre-van de Waal HA, Vulsma T, Wit JM, Rouwe CW, Reeser HM, Gosen JJ, Rongen-Westerlaken C, Drop SL. Yearly stepwise increments of the growth hormone dose results in a better growth response after four years in girls with Turner syndrome. Dutch Working Group on Growth Hormone. J Clin Endocrinol Metab. 1996 Nov;81(11):4013-21. doi: 10.1210/jcem.81.11.8923853.

    PMID: 8923853RESULT

  • Sas TC, Gerver WJ, de Bruin R, Stijnen T, de Muinck Keizer-Schrama SM, Cole TJ, van Teunenbroek A, Drop SL. Body proportions during long-term growth hormone treatment in girls with Turner syndrome participating in a randomized dose-response trial. J Clin Endocrinol Metab. 1999 Dec;84(12):4622-8. doi: 10.1210/jcem.84.12.6225.

    PMID: 10599729RESULT

  • Sas TC, Cromme-Dijkhuis AH, de Muinck Keizer-Schrama SM, Stijnen T, van Teunenbroek A, Drop SL. The effects of long-term growth hormone treatment on cardiac left ventricular dimensions and blood pressure in girls with Turner's syndrome. Dutch Working Group on Growth Hormone. J Pediatr. 1999 Oct;135(4):470-6. doi: 10.1016/s0022-3476(99)70170-8.

    PMID: 10518081RESULT

  • Van Pareren YK, De Muinck Keizer-Schrama SM, Stijnen T, Sas TC, Drop SL. Effect of discontinuation of long-term growth hormone treatment on carbohydrate metabolism and risk factors for cardiovascular disease in girls with Turner syndrome. J Clin Endocrinol Metab. 2002 Dec;87(12):5442-8. doi: 10.1210/jc.2002-020789.

    PMID: 12466334RESULT

  • van Pareren YK, de Muinck Keizer-Schrama SM, Stijnen T, Sas TC, Jansen M, Otten BJ, Hoorweg-Nijman JJ, Vulsma T, Stokvis-Brantsma WH, Rouwe CW, Reeser HM, Gerver WJ, Gosen JJ, Rongen-Westerlaken C, Drop SL. Final height in girls with turner syndrome after long-term growth hormone treatment in three dosages and low dose estrogens. J Clin Endocrinol Metab. 2003 Mar;88(3):1119-25. doi: 10.1210/jc.2002-021171.

    PMID: 12629094RESULT

  • van Pareren YK, Duivenvoorden HJ, Slijper FM, Koot HM, Drop SL, de Muinck Keizer-Schrama SM. Psychosocial functioning after discontinuation of long-term growth hormone treatment in girls with Turner syndrome. Horm Res. 2005;63(5):238-44. doi: 10.1159/000085841. Epub 2005 May 17.

    PMID: 15900109RESULT

  • Sas TC, de Muinck Keizer-Schrama SM, Stijnen T, Jansen M, Otten BJ, Hoorweg-Nijman JJ, Vulsma T, Massa GG, Rouwe CW, Reeser HM, Gerver WJ, Gosen JJ, Rongen-Westerlaken C, Drop SL. Normalization of height in girls with Turner syndrome after long-term growth hormone treatment: results of a randomized dose-response trial. J Clin Endocrinol Metab. 1999 Dec;84(12):4607-12. doi: 10.1210/jcem.84.12.6241.

    PMID: 10599727RESULT

Related Links

MeSH Terms

Conditions

Genetic Diseases, InbornTurner Syndrome

Interventions

Human Growth HormoneEstrogens

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesSex Chromosome DisordersChromosome DisordersGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

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

January 20, 2012

First Posted

January 25, 2012

Study Start

November 1, 1989

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

NL(1)