Genetic Disorder, Turner Syndrome
Conditions
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.
Interventions
DRUGsomatropin
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
DRUGoestrogen
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
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Turner Syndrome * Well documented growth rate during the previous year * Height below the 50th percentile for the age in Dutch children * Normal thyroid function
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Final height | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio between change in bone age and change in chronological age | — |
| Age at onset of puberty | — |
| Adverse events | — |
| Height velocity (cm/year) | — |
Countries
Netherlands
Outcome results
None listed