Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001029684
Ethics application status
Approved
Date submitted
18/09/2014
Date registered
24/09/2014
Date last updated
24/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Does peripheral quantitative computed tomography (pQCT) measures contribute to the understanding of bone fragility in older patients with low-trauma fracture?
Scientific title
Does peripheral quantitative computed tomography (pQCT) measures contribute to the understanding of bone fragility in older patients with low-trauma fracture?
Secondary ID [1] 285362 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 293089 0
low-trauma osteoporotic fracture 293125 0
Condition category
Condition code
Musculoskeletal 293364 293364 0 0
Osteoporosis
Injuries and Accidents 293394 293394 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will recruit patients with osteoporotic fracture presenting to outpatients clinic. The patients will have peripheral quantitative computed tomography (pQCT) test besides the routine dual-energy x-ray absorptiometry (DXA) test during one one-hour site visit. This is a cross-sectional study and all the patients will only have one site visit. DXA is a routine test for patients with low-trauma fracture. Patients will still have DXA examinations even if they don't participate in this project.
Intervention code [1] 290277 0
Not applicable
Comparator / control treatment
There is no control intervention in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293193 0
bone strength of one of the limbs without fracture as determined by pQCT
Timepoint [1] 293193 0
Baseline.
Secondary outcome [1] 310558 0
Bone mineral density of hip, vertebre or total body, as determined by DXA
Timepoint [1] 310558 0
Baseline.

Eligibility
Key inclusion criteria
1. Aged 50 years or greater;
2. One or more low-trauma fractures within the past three months;
3. Informed verbal and written consent provided.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior diagnosis of osteoporosis;
2. Prolonged (>3 months) use of osteoporosis therapy in the past 2 years;
3. Prior therapy with teripatratide or strontium ranelate;
4. Unstable doses of hormone replacement therapy;
5. Patients with secondary causes of low bone density, e.g. hyperthyroidism, diabetes, Vitamin D deficiency, alcoholism, smoking.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
In the absence of preliminary data we have selected an opportunistic sample of 85 subjects. This sample size will be large enough to provide valuable information and is feasible based on clinic attendance rates.
Multivariable analysis will be used to determine the correlations between low-trauma fracture risk and these factors while adjusting for the differences between groups and potential confounders.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/09/2014
Actual
Date of last participant enrolment
Anticipated
31/08/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289977 0
University
Name [1] 289977 0
The University of Melbourne
Country [1] 289977 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 288663 0
None
Name [1] 288663 0
Address [1] 288663 0
Country [1] 288663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291687 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 291687 0
Grattan Street
Parkville VIC 3052
Ethics committee country [1] 291687 0
Australia
Date submitted for ethics approval [1] 291687 0
30/07/2014
Approval date [1] 291687 0
25/08/2014
Ethics approval number [1] 291687 0
2014.143

Summary
Brief summary
Dual-energy X-ray absorptiometry (DXA) is well established to assess bone strength in clinical settings; however, it
has many limitations. This research aims to evaluate the role of peripheral quantitative computed tomography
(pQCT), an alternative bone density testing method that is believed to provide more information than DXA, for the
assessment of bone strength. We will recruit patients with osteoporotic fracture and evaluate whether pQCT
measures are associated with bone strength. We have already obtained normal pQCT measures in healthy young
adults and calculated the means and standard deviations. We will compare patients’ pQCT results with the normal
values to achieve our research aim. We may also find new factors that may contribute to fracture prediction in older
patients.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 187 187 0 0
/AnzctrAttachments/367114-Study protocol 20140818.docx
Attachments [2] 188 188 0 0
/AnzctrAttachments/367114-PICF 2014.143-20140818.doc
Attachments [3] 189 189 0 0
/AnzctrAttachments/367114-Ethics approval.pdf

Contacts
Principal investigator
Name 51514 0
Prof John D Wark
Address 51514 0
Department of Medicine, Royal Melbourne Hospital,
Grattan Street, Parkville, VIC 3052
Country 51514 0
Australia
Phone 51514 0
+61 (0)3 9342 7109
Fax 51514 0
Email 51514 0
jdwark@unimelb.edu.au
Contact person for public queries
Name 51515 0
Hongyuan Jiang
Address 51515 0
Department of Medicine, Royal Melbourne Hospital,
Grattan Street, Parkville, VIC 3052
Country 51515 0
Australia
Phone 51515 0
+61 (0)3 8344 2712
Fax 51515 0
Email 51515 0
hongyuanj@student.unimelb.edu.au
Contact person for scientific queries
Name 51516 0
Hongyuan Jiang
Address 51516 0
Department of Medicine, Royal Melbourne Hospital,
Grattan Street, Parkville, VIC 3052
Country 51516 0
Australia
Phone 51516 0
+61 (0)3 8344 2712
Fax 51516 0
Email 51516 0
hongyuanj@student.unimelb.edu.au

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
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Documents added automatically
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