Trial registered on ANZCTR


Trial ID
ACTRN12605000446662
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
21/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of the safety and efficacy of human growth hormone replacement therapy in adults in relation to diagnostic criteria and different dosage algorithms
Scientific title
Investigation of the safety and efficacy of human growth hormone replacement therapy in adults in relation to diagnostic criteria and different dosage algorithms
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
GH deficient adults 561 0
Condition category
Condition code
Metabolic and Endocrine 636 636 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GH replacement at 3 different doses for 6 months.
Intervention code [1] 341 0
Treatment: drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 745 0
Change in lean body mass
Timepoint [1] 745 0
Primary outcome [2] 746 0
GH-related adverse effects after 3 and 6 months growth hormone replacement
Timepoint [2] 746 0
Secondary outcome [1] 1527 0
IGF-1 levels
Timepoint [1] 1527 0
Secondary outcome [2] 1528 0
Quality of life
Timepoint [2] 1528 0
Secondary outcome [3] 1529 0
Whole body leucine turnover,
Timepoint [3] 1529 0
Secondary outcome [4] 1530 0
Resting energy expenditure and fat oxidation
Timepoint [4] 1530 0
After 2 weeks and 12 weeks growth hormone replacement.

Eligibility
Key inclusion criteria
Adults with GH deficiency.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant pulmonary, cardiac, hepatic or renal disease or cancer.

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)
Central randomisation by phone/fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was generated by computer software at St Thomas' Hospital, London, UK.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 696 0
Commercial sector/Industry
Name [1] 696 0
Eli Lilly
Address [1] 696 0
Country [1] 696 0
Funding source category [2] 697 0
Government body
Name [2] 697 0
NHMRC
Address [2] 697 0
Country [2] 697 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Country
Australia
Secondary sponsor category [1] 582 0
None
Name [1] 582 0
Nil
Address [1] 582 0
Country [1] 582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1900 0
St Vincent's Hospital
Ethics committee address [1] 1900 0
Ethics committee country [1] 1900 0
Australia
Date submitted for ethics approval [1] 1900 0
Approval date [1] 1900 0
Ethics approval number [1] 1900 0
Ethics committee name [2] 1901 0
Garvan Institute of Medical Research
Ethics committee address [2] 1901 0
Ethics committee country [2] 1901 0
Australia
Date submitted for ethics approval [2] 1901 0
Approval date [2] 1901 0
Ethics approval number [2] 1901 0

Summary
Brief summary
The primary aim was to determine whether a lower dose of GH is as effective as higher doses at increasing lean body mass and whether GH-related side-effects are reduced with a lower dose.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35238 0
Address 35238 0
Country 35238 0
Phone 35238 0
Fax 35238 0
Email 35238 0
Contact person for public queries
Name 9530 0
Professor Ken Ho
Address 9530 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 9530 0
Australia
Phone 9530 0
+61 2 92958482
Fax 9530 0
+61 2 92958481
Email 9530 0
k.ho@garvan.org.au
Contact person for scientific queries
Name 458 0
Dr Morton Burt
Address 458 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 458 0
Australia
Phone 458 0
+61 2 92958484
Fax 458 0
+61 2 92958481
Email 458 0
m.burt@garvan.org.au