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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01518062
Other study ID # GHTUR/BPD/5-13
Secondary ID
Status Completed
Phase Phase 4
First received January 20, 2012
Last updated January 17, 2017
Start date November 1989
Est. completion date September 2003

Study information

Verified date January 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date September 2003
Est. primary completion date September 2003
Accepts healthy volunteers No
Gender Female
Age group 2 Years to 11 Years
Eligibility 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

Study Design


Intervention

Drug:
somatropin
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
somatropin
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
somatropin
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
oestrogen
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

Locations

Country Name City State
Netherlands Novo Nordisk Investigational Site Alphen a/d Rijn

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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 Grou — View 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 growt — View 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 — View 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 Endocrino — View 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, Rouwé CW, Reeser HM, Gerver WJ, Gosen JJ, Rongen-Westerlaken C, Drop SL. Final height in girls with turner syndrome after — View 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. — View Citation

van Teunenbroek A, de Muinck Keizer-Schrama SM, Stijnen T, Jansen M, Otten BJ, Delemarre-van de Waal HA, Vulsma T, Wit JM, Rouwé CW, Reeser HM, Gosen JJ, Rongen-Westerlaken C, Drop SL. Yearly stepwise increments of the growth hormone dose results in a bet — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Final height
Secondary Height velocity (cm/year)
Secondary Ratio between change in bone age and change in chronological age
Secondary Age at onset of puberty
Secondary Adverse events
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