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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00184678




Registration number
NCT00184678
Ethics application status
Date submitted
13/09/2005
Date registered
16/09/2005
Date last updated
13/01/2017

Titles & IDs
Public title
Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency
Scientific title
Effect of Two Years of Treatment With Norditropin® SimpleXx® on Bone Mineral Density in Young Adults With Childhood-Onset Growth Hormone Deficiency
Secondary ID [1] 0 0
GHLIQUID-1369
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth Hormone Disorder 0 0
Adult Growth Hormone Deficiency 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - somatropin

Treatment: Drugs: somatropin


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in bone mineralisation
Timepoint [1] 0 0
After 2 years treatment
Secondary outcome [1] 0 0
Other markers of bone mineral content.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Child-hood onset growth hormone deficiency

- Subjects received growth hormone replacement therapy during pre-puberty and puberty
Minimum age
18 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- GH treatment during the month preceding randomisation

- Treatment within the previous 6 months with medication that may affect bone mineral
density

- Diseases which may affect bone metabolism

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Auckland
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Hamilton
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
1 - Auckland
Recruitment postcode(s) [3] 0 0
2303 - Hamilton
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
France
State/province [3] 0 0
Le Kremlin-bicetre
Country [4] 0 0
France
State/province [4] 0 0
MARSEILLE Cédex 05
Country [5] 0 0
France
State/province [5] 0 0
TOULOUSE cedex
Country [6] 0 0
Germany
State/province [6] 0 0
Essen
Country [7] 0 0
Germany
State/province [7] 0 0
Frankfurt
Country [8] 0 0
Germany
State/province [8] 0 0
Heidelberg
Country [9] 0 0
Germany
State/province [9] 0 0
Krefeld
Country [10] 0 0
Germany
State/province [10] 0 0
Leipzig
Country [11] 0 0
Germany
State/province [11] 0 0
Magdeburg
Country [12] 0 0
Hungary
State/province [12] 0 0
Budapest
Country [13] 0 0
Hungary
State/province [13] 0 0
Szeged
Country [14] 0 0
Norway
State/province [14] 0 0
Oslo
Country [15] 0 0
Poland
State/province [15] 0 0
Cracow
Country [16] 0 0
Poland
State/province [16] 0 0
Gdansk
Country [17] 0 0
Poland
State/province [17] 0 0
Szczecin
Country [18] 0 0
Poland
State/province [18] 0 0
Warszawa
Country [19] 0 0
Poland
State/province [19] 0 0
Wroclaw
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Sweden
State/province [21] 0 0
Göteborg
Country [22] 0 0
Switzerland
State/province [22] 0 0
Bern
Country [23] 0 0
Switzerland
State/province [23] 0 0
Lausanne
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Glasgow
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial is conducted in Europe. Growth Hormone in young adults with growth hormone
deficiency in childhood. This trial compares a treated group of patients with an untreated
group of patients.
Trial website
https://clinicaltrials.gov/show/NCT00184678
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications