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

Primary Purpose

Genetic Disorder, Turner Syndrome

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
somatropin
somatropin
somatropin
oestrogen
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genetic Disorder

Eligibility Criteria

2 Years - 11 Years (Child)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low dose

Medium dose

High dose

Arm Description

Outcomes

Primary Outcome Measures

Final height

Secondary Outcome Measures

Height velocity (cm/year)
Ratio between change in bone age and change in chronological age
Age at onset of puberty
Adverse events

Full Information

First Posted
January 20, 2012
Last Updated
January 17, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01518062
Brief Title
Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome
Official Title
Dose Response Trial of Biosynthetic Authentic Human Growth Hormone and Induction of Puberty With 17b Oestradiol in Girls With Turner's Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 1989 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Disorder, Turner Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Title
Medium dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
oestrogen
Intervention Description
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
Primary Outcome Measure Information:
Title
Final height
Secondary Outcome Measure Information:
Title
Height velocity (cm/year)
Title
Ratio between change in bone age and change in chronological age
Title
Age at onset of puberty
Title
Adverse events

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Alphen a/d Rijn
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
8923853
Citation
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.
Results Reference
result
PubMed Identifier
10599729
Citation
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.
Results Reference
result
PubMed Identifier
10518081
Citation
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.
Results Reference
result
PubMed Identifier
12466334
Citation
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.
Results Reference
result
PubMed Identifier
12629094
Citation
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.
Results Reference
result
PubMed Identifier
15900109
Citation
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.
Results Reference
result
PubMed Identifier
10599727
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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