Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000266460
Ethics application status
Approved
Date submitted
27/03/2025
Date registered
10/04/2025
Date last updated
10/04/2025
Date data sharing statement initially provided
10/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Opportunistic osteoporosis screening using pre versus post contrast computed tomography compared with dual-energy x-ray
Scientific title
Effect of opportunistic osteoporosis screening using pre versus post contrast computed tomography compared with dual-energy x-ray on bone mineral density assessment
Secondary ID [1] 314048 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoporosis 336792 0
Condition category
Condition code
Musculoskeletal 333286 333286 0 0
Osteoporosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessment of bone mineral density on pre vs post contrast computed tomography compared with dual energy x-ray. Many patients have abdominal CT imaging performed to assess for other pathology. If bone mineral density can be opportunistically assessed on these studies with or without IV contrast then patients can be screened for osteoporosis or the need for a formal dual energy x-ray scan to assess for osteoporosis.
For each patient a DEXA scan was taken at visit one (pre-CT timepoint) and the subsequent CT obtained within 1 year of this.
Radiologist reviewed each DEXA and CT scan with software used to measure bone mineral density in Hounsfield units.
Data was obtained in a retrospective manner from a picture archiving system.
Duration of observation was one year.
Intervention code [1] 330627 0
Early Detection / Screening
Comparator / control treatment
The comparator is DEXA scan.
Control group
Active

Outcomes
Primary outcome [1] 340854 0
Bone mineral density
Timepoint [1] 340854 0
Within 1 year of the baseline study
Secondary outcome [1] 445278 0
Differences in Hounsfield units of bones in pre versus post contrast CT
Timepoint [1] 445278 0
Within 1 year of the baseline study

Eligibility
Key inclusion criteria
Patients who have had an abdominal CT scan and DEXA scan within 12 months of each other.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with vertebral body fractures, lesions and previous vertebral instrumentation were excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2025
Date of last participant enrolment
Anticipated
Actual
1/01/2025
Date of last data collection
Anticipated
Actual
31/01/2025
Sample size
Target
155
Accrual to date
Final
155
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318554 0
Hospital
Name [1] 318554 0
Princess Alexandra Hospital
Country [1] 318554 0
Australia
Primary sponsor type
Individual
Name
Dr James Lee - Princess Alexandra Hospital
Address
Country
Australia
Secondary sponsor category [1] 320952 0
None
Name [1] 320952 0
Address [1] 320952 0
Country [1] 320952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317154 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317154 0
Ethics committee country [1] 317154 0
Australia
Date submitted for ethics approval [1] 317154 0
02/09/2024
Approval date [1] 317154 0
02/12/2024
Ethics approval number [1] 317154 0

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

Contacts
Principal investigator
Name 140182 0
Dr James Lee
Address 140182 0
Princess Alexandra Hospital. 199 Ipswich Road, Woolloongabba Qld 4102
Country 140182 0
Australia
Phone 140182 0
+61 450006561
Fax 140182 0
Email 140182 0
[email protected]
Contact person for public queries
Name 140183 0
James Lee
Address 140183 0
Princess Alexandra Hospital. 199 Ipswich Road, Woolloongabba Qld 4102
Country 140183 0
Australia
Phone 140183 0
+61 450006561
Fax 140183 0
Email 140183 0
[email protected]
Contact person for scientific queries
Name 140184 0
James Lee
Address 140184 0
Princess Alexandra Hospital. 199 Ipswich Road, Woolloongabba Qld 4102
Country 140184 0
Australia
Phone 140184 0
+61 450006561
Fax 140184 0
Email 140184 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24576Ethical approval    112106 Low Risk approval MD.pdf



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.