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Trial registered on ANZCTR


Registration number
ACTRN12605000532606
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
28/09/2005
Date last updated
28/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
How does raloxifene influence the effects of growth hormone replacement
Scientific title
Modulation of growth hormone action during growth hormone replacement in growth hormone-deficient women: comparison of raloxifene and oral oestrogen
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypopituitary women 657 0
Condition category
Condition code
Metabolic and Endocrine 730 730 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Raloxifene (60 mg daily) for 6 - 18 months
17 beta oestradiol (2 mg) for 6 - 18 months
recombinant uman growth hormone (Humaloge) (0.5 mg daily) for 24 months
Intervention code [1] 526 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 900 0
Short term measurements of biochemical markers of the GH-IGF-axis as well as substrate metabolism and protein turnover
Timepoint [1] 900 0
At baseline, after 1 month of growth hormone alone, growth hormone + raloxifene or growth hormone + oestradiol.
Primary outcome [2] 901 0
Long term effects on body composition measured by DEXA
Timepoint [2] 901 0
At baseline, after 6 and 12 and 24 months.
Secondary outcome [1] 1756 0
Changes in bone turnover markers and cardiovascular risk factors are measured:
Timepoint [1] 1756 0
At baseline, after 1 month of growth hormone alone, growth hormone + raloxifene or growth hormone + oestradiol
Secondary outcome [2] 1757 0
Changes in bone turnover markers and cardiovascular risk factors are measured:
Timepoint [2] 1757 0
On long term treatment with growth hormone + raloxifene or growth hormone + oestradiol after 6, 12 and 24 months.
Secondary outcome [3] 1758 0
Long term effects on body composition measured by DEXA.
Timepoint [3] 1758 0
At baseline, after 6 and 12 and 24 months.

Eligibility
Key inclusion criteria
Hypopituitarism (deficient in growth hormone and sex steroids).
Minimum age
Not stated
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
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] 811 0
Government body
Name [1] 811 0
NHMRC
Address [1] 811 0
Country [1] 811 0
Australia
Primary sponsor type
Hospital
Name
Department of Endocrinology, St Vincents Hospital Sydney
Address
Country
Australia
Secondary sponsor category [1] 679 0
None
Name [1] 679 0
none
Address [1] 679 0
Country [1] 679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2079 0
Garvan Institute of Medical Research
Ethics committee address [1] 2079 0
Ethics committee country [1] 2079 0
Australia
Date submitted for ethics approval [1] 2079 0
Approval date [1] 2079 0
Ethics approval number [1] 2079 0

Summary
Brief summary
Raloxifene is a member of a family of compounds called selective estrogen receptor modulators (SERMS) that exert many of the beneficial effects of estrogen replacement without the associated increase in risk of breast and uterine cancer. Growth hormone (GH) replacement is beneficial in adults with hypopituitarism. Most GH deficient women also require oestrogen replacement. Oral oestrogens antagonise GH action at the liver, thereby reducing its beneficial effects on body composition and metabolism. The aim of this study is to investigate whether SERMs exert less of a negative influence on the effects of GH replacement, and therefore would be superior to conventional estrogen replacement in this setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35701 0
Address 35701 0
Country 35701 0
Phone 35701 0
Fax 35701 0
Email 35701 0
Contact person for public queries
Name 9715 0
Dr Ken Ho
Address 9715 0
Professor of Medicine
Head
Pituitary Research Unit
Garvan Institute Chairman
Department of Endocrinology
Garvan Institute of Medical Research
St Vincents Hospital
384 Victoria Street
Darlinghurst NSW 2010
Country 9715 0
Australia
Phone 9715 0
+61 2 92958203
Fax 9715 0
+61 2 92958411
Email 9715 0
k.ho@garvan.unsw.edu.au
Contact person for scientific queries
Name 643 0
Dr Udo Meinhardt
Address 643 0
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
Country 643 0
Australia
Phone 643 0
+61 2 92958486
Fax 643 0
+61 2 92958411
Email 643 0
u.meinhardt@garvan.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary