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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/02/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2006
Sample size
Target
Accrual to date
Final
161
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00184678