Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Dose Response Trial of Biosynthetic Authentic Human Growth Hormone and Induction of Puberty With 17b Oestradiol in Girls With Turner's Syndrome

Conditions
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Genetic Disorder, Turner Syndrome

Intervention / Treatment
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* Drug: somatropin
* Drug: somatropin
* Drug: somatropin
* Drug: oestrogen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br> | Drug: somatropin<br>* 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<br>Drug: oestrogen<br>* 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<br>|
| Experimental: Medium dose<br> | Drug: somatropin<br>* Initial dose 4 IU/m^2 body surface the first year, then 6 IU/m^2 body surface for 3 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection<br>Drug: oestrogen<br>* 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<br>|
| Experimental: High dose<br> | Drug: somatropin<br>* Initial dose 4 IU/m^2 body surface the first year, then 6 IU/m^2 body surface, the second year and finally 8 IU/m^2 body surface for 2 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection<br>Drug: oestrogen<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final height |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height velocity (cm/year) |  |  | 
| Ratio between change in bone age and change in chronological age |  |  | 
| Age at onset of puberty |  |  | 
| Adverse events |  |  |