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Trial registered on ANZCTR


Registration number
ACTRN12607000610437
Ethics application status
Approved
Date submitted
26/11/2007
Date registered
28/11/2007
Date last updated
5/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The bone effects of pioglitazone
Scientific title
A randomized controlled trial of the effects of pioglitazone on bone density and bone turnover in type 2 diabetes mellitus
Secondary ID [1] 259739 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 2582 0
Osteoporosis 2583 0
Condition category
Condition code
Metabolic and Endocrine 2692 2692 0 0
Diabetes
Musculoskeletal 2693 2693 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pioglitazone 30mg per oral daily for 12 months
Intervention code [1] 2316 0
Treatment: Drugs
Comparator / control treatment
Placebo, sugar pill, per oral
Control group
Placebo

Outcomes
Primary outcome [1] 3593 0
Change in lumbar spine bone density, measured by dual energy xray absorptiometry
Timepoint [1] 3593 0
1 year after randomization
Secondary outcome [1] 6016 0
Change in total hip bone density, measured by dual energy xray absorptiometry
Timepoint [1] 6016 0
1 year after randomization
Secondary outcome [2] 6017 0
Chnage in biochemical markers of bone formation, assayed in serum
Timepoint [2] 6017 0
1 year after randomization

Eligibility
Key inclusion criteria
- Type 2 diabetes mellitus (T2DM), as defined by fasting blood glucose > 7mmol/L and/or serum glucose > 11mmol/L 2h after ingesting 75g oral glucose.
- impaired glucose tolerance, as defined by fasting blood glucose < 6-7 mmol/L and/or serum glucose 7.8-11mmol/L 2h after ingesting 75g oral glucose
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical Conditions
- subjects with type 2 diabetes mellitus (T2DM) deemed to require early glitazone treatment and meeting Pharmac criteria for funded supply
- renal impairment (estimated glomerular filtration rate < 30ml/min).
- congestive heart failure, New York Heart Association Grade 2 or higher
- clinical liver disease.
- untreated thyroid dysfunction.
- concurrent major systemic illness, including malignancy.
- metabolic bone diseases, or serum alkaline phosphatase (ALP) > 2x normal limit.
- primary hyperparathyroidism.
- Bone mineral density (BMD) T score < -2.0 at total hip or spine
- previous fragility fracture (forearm, humerus, hip, vertebra)
- body weight >120kg

2.2.2 Medications
- 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 alter bone metabolism
- current use of thiazolidinediones

Insulin use is not an exclusion criterion, but insulin dose should be stable (+/- 20%) for 3 months before enrolment.

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)
Allocation is concealed. Allocation involves contacting the holder of the allocation schedule who is "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be undertaken using a variable block size schedule, based on computer-generated random numbers, stratified for age, menopausal status, and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a 1 year randomized interventional protocol, with a 1 year observational follow-up period
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2008
Actual
1/10/2008
Date of last participant enrolment
Anticipated
30/04/2011
Actual
30/04/2011
Date of last data collection
Anticipated
Actual
30/04/2012
Sample size
Target
100
Accrual to date
Final
86
Recruitment outside Australia
Country [1] 697 0
New Zealand
State/province [1] 697 0

Funding & Sponsors
Funding source category [1] 2834 0
Government body
Name [1] 2834 0
Health Research Council of New Zealand
Country [1] 2834 0
New Zealand
Primary sponsor type
Individual
Name
Andrew Grey
Address
Department of Medicine
University of Auckland
Private bag 92019
Auckland
Country
New Zealand
Secondary sponsor category [1] 2553 0
University
Name [1] 2553 0
University of Auckland
Address [1] 2553 0
Private Bag 92019
Auckland
Country [1] 2553 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4762 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 4762 0
Ethics committee country [1] 4762 0
New Zealand
Date submitted for ethics approval [1] 4762 0
20/11/2007
Approval date [1] 4762 0
04/04/2008
Ethics approval number [1] 4762 0
NTY/07/12/128

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

Contacts
Principal investigator
Name 28212 0
A/Prof Andrew Grey
Address 28212 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland
new Zealand
Country 28212 0
New Zealand
Phone 28212 0
+6499234423
Fax 28212 0
Email 28212 0
[email protected]
Contact person for public queries
Name 11369 0
Anne Horne
Address 11369 0
Osteoporosis Research Group
Department of Medicine
Level 3,
Support Building
Auckland City Hospital
Park Rd.,
Grafton,
Auckland
Country 11369 0
New Zealand
Phone 11369 0
64-9-3078970
Fax 11369 0
Email 11369 0
[email protected]
Contact person for scientific queries
Name 2297 0
Andrew Grey
Address 2297 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland
Country 2297 0
New Zealand
Phone 2297 0
64-9-3737599, ext 84423
Fax 2297 0
Email 2297 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
SourceTitleYear of PublicationDOI
Dimensions AIThe skeletal effects of pioglitazone in type 2 diabetes or impaired glucose tolerance: a randomized controlled trial2013https://doi.org/10.1530/eje-13-0793
N.B. These documents automatically identified may not have been verified by the study sponsor.