Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000218695
Ethics application status
Approved
Date submitted
22/08/2005
Date registered
26/08/2005
Date last updated
10/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Rosiglitazone on Bone Metabolism
Scientific title
A three month randomised, double-blind, placebo-controlled trial to determine the effect of rosiglitazone on bone and calcium metabolism in normal post menopausal women.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal Post Menopausal Women 301 0
Condition category
Condition code
Reproductive Health and Childbirth 344 344 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8mg rosiglitazone daily over 3 months
Intervention code [1] 221 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 399 0
Change in bone turnover markers in the rosiglitazone group compared to the change in the control group over 3 months
Timepoint [1] 399 0
3 months
Secondary outcome [1] 869 0
Not applicable
Timepoint [1] 869 0
Not applicable

Eligibility
Key inclusion criteria
Postmenopausal 5 yrs or more.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal impairment (serum creatinine >0.15 mmol/L), congestive heart failure, chronic liver disease, untreated hypothyroidism or hyperthyroidism, concurrent major systemic illness, malignancy, active major gastrointestinal disease, metabolic bone diseases, or serum ALP > 2x normal limit, diabetes mellitus, primary hyperparathyroidism, > 2 hospital admission within 6 months of study entry. Use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding 12 months, current or past use of bisphosphonate therapy, use of hormone replacement therapy within the last 12 months, use of other medication known to cause osteoporosis or interfere with bone metabolism, current or past use of thiazolidinediones.

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)
Medication was dispensed by a doctor not involved with study participants into numbered containers. All study personnel with patient contact were blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers in variable blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 141 0
New Zealand
State/province [1] 141 0

Funding & Sponsors
Funding source category [1] 404 0
Government body
Name [1] 404 0
Health Research Council of New Zealand
Country [1] 404 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor A Grey
Address
Bone Research Group Department of Medicine Auckland University Private Bag 92 019 Auckland 1020
Country
New Zealand
Secondary sponsor category [1] 327 0
University
Name [1] 327 0
University of Auckland Bone Research Group
Address [1] 327 0
Bone Research Group Department of Medicine Auckland University Private Bag 92 019 Auckland 1020
Country [1] 327 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1389 0
Auckland University
Ethics committee address [1] 1389 0
Ethics committee country [1] 1389 0
Australia
Date submitted for ethics approval [1] 1389 0
Approval date [1] 1389 0
Ethics approval number [1] 1389 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35397 0
Address 35397 0
Country 35397 0
Phone 35397 0
Fax 35397 0
Email 35397 0
Contact person for public queries
Name 9410 0
Diana Wattie
Address 9410 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 9410 0
New Zealand
Phone 9410 0
+64 9 3078970
Fax 9410 0
+64 9 3737677
Email 9410 0
d.wattie@auckland.ac.nz
Contact person for scientific queries
Name 338 0
Associate Professor Grey
Address 338 0
Bone Research Group
Department of Medicine
Auckland University
Private Bag 92 019
Auckland 1020
Country 338 0
New Zealand
Phone 338 0
+64 9 3737599
Fax 338 0
+64 9 3737677
Email 338 0
a.grey@auckland.ac.nz

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.