Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000642684
Ethics application status
Approved
Date submitted
2/09/2005
Date registered
14/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of glucocorticoid-induced protein wasting
Scientific title
Impact of growth hormone and androgens on protein metabolism in subjects with polymyalgia rheumatica and inflammatory arthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long-term glucocorticoid users with polymyalgia rheumatica 772 0
Inflammatory arthritis 773 0
Condition category
Condition code
Inflammatory and Immune System 848 848 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two weeks of growth hormone and androgens (testosterone for men, DHEA for women) alone and in combination.
Intervention code [1] 336 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 1087 0
Impact of growth hormone on protein turnover
Timepoint [1] 1087 0
After 2 weeks of therapy
Primary outcome [2] 1088 0
Impact of androgen (testosterone for men, DHEA for women) on protein turnover
Timepoint [2] 1088 0
After 2 weeks of therapy
Primary outcome [3] 1089 0
Impact of the combination of growth hormone and androgen on protein turnover
Timepoint [3] 1089 0
After 2 weeks of therapy
Secondary outcome [1] 2021 0
Impact of growth hormone. androgen (testosterone for men, DHEA for women) and the combination of growth hormone and androgen on insulin sensitivity.
Timepoint [1] 2021 0
Secondary outcome [2] 2022 0
Resting energy expenditure and fat oxidation.
Timepoint [2] 2022 0
After 2 weeks of therapy.

Eligibility
Key inclusion criteria
Receiving prednisone for > 6 months for polymyalgia rheumatica or inflammatory arthritis.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes mellitus, cancer, liver or kidney failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 934 0
Government body
Name [1] 934 0
NHMRC
Country [1] 934 0
Australia
Funding source category [2] 935 0
Commercial sector/Industry
Name [2] 935 0
Pharmacia Endocrine Care International, Fund for Research and Education
Country [2] 935 0
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
Country
Australia
Secondary sponsor category [1] 793 0
None
Name [1] 793 0
Nil
Address [1] 793 0
Country [1] 793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2233 0
St Vincent's Hospital and Garvan Institute of Medical Research
Ethics committee address [1] 2233 0
Ethics committee country [1] 2233 0
Australia
Date submitted for ethics approval [1] 2233 0
Approval date [1] 2233 0
Ethics approval number [1] 2233 0

Summary
Brief summary
The primary purpose is to determine whether growth hormone and androgens alter protein metabolism in a way that will reduce protein loss in long-term glucocorticoid users. If so they may be a potential therapy to reduce the skin thinning and muscle weakness that occurs during longterm glucocorticoid use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35211 0
Address 35211 0
Country 35211 0
Phone 35211 0
Fax 35211 0
Email 35211 0
Contact person for public queries
Name 9525 0
Professor Ken Ho
Address 9525 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 9525 0
Australia
Phone 9525 0
+61 2 92958482
Fax 9525 0
+61 2 92958481
Email 9525 0
[email protected]
Contact person for scientific queries
Name 453 0
Dr Morton Burt
Address 453 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 453 0
Australia
Phone 453 0
+61 2 92958484
Fax 453 0
+61 2 92958481
Email 453 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.