Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000955415p
Ethics application status
Submitted, not yet approved
Date submitted
30/07/2025
Date registered
1/09/2025
Date last updated
1/09/2025
Date data sharing statement initially provided
1/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Coronary Artery Stenosis in Anti-Resorptive Users (CAESAR) Imaging Study
Scientific title
Coronary Artery Stenosis in Anti-Resorptive Users adults with osteoporosis (CAESAR) Imaging Study
Secondary ID [1] 314975 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 338367 0
Coronary artery calcification 338368 0
Condition category
Condition code
Musculoskeletal 334666 334666 0 0
Osteoporosis
Cardiovascular 334804 334804 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical measurements: weight and height will be taken at the site.

Bone Imaging:
Seven scan will be performed. Four will be using a high
resolution peripheral quantitative computed tomography
scanner (HR-pQCT) at the left leg and left arm.
Participants will be undergoing this scan because they have
enrolled in this study. These four scans will take approx. 30-40 minutes in total (as per protocol document).
Three scans will be using dual energy x-ray absorbtiometry
(DEXA) to assess bone mineral density (BMD) at the hip and
spine. These three scans will take approximately 5-10 minutes in total (as per protocol document).

These scans will be conducted only once, all within the same session. No contrast dyes will be used for these scans.

Heart Imaging:
One scan will be performed using a
computed tomography coronary angiogram (CTCA) which will check
the vessels that supply blood to the heart. This will take approx. 20-30 minutes (as per protocol document). Contrast dye will be used for this scan. Typically 50-100mL IV contrast is used, however the exact amount depends on the patients weight and other factors which will be considered by the medical team. This scan will be conducted either prior to or after the bone imaging, depending on radiologist/cardiologist availability. Most patients have had previous CTCA scans completed in the original CAESAR study. Typically, CAC screening is typically done on approximate 5- yearly basis thus, the timeline is optimal for helping participants’ health and wellbeing and guiding further management. CAC will be compared to this previous scan.

One questionnaire will be completed over the phone, which will take approximately 30 minutes to complete. This will be done prior to the in-person imaging.
Intervention code [1] 331718 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342339 0
Coronary artery calcification (CAC) score
Timepoint [1] 342339 0
Within 2-4 of weeks of enrolment after questionnaire
Primary outcome [2] 342442 0
Bone mineral density (BMD)
Timepoint [2] 342442 0
Within 2-4 of weeks of enrolment after questionnaire
Secondary outcome [1] 450830 0
Osteoporosis medication changes
Timepoint [1] 450830 0
At enrolment
Secondary outcome [2] 450831 0
Osteoporosis medication adverse effects (Have you experienced any dental problems, fractures, heart burn/reflux?)
Timepoint [2] 450831 0
At enrolment
Secondary outcome [3] 450832 0
Incidence of heart attacks
Timepoint [3] 450832 0
At enrolment
Secondary outcome [4] 450833 0
Incidence of heart failure (Have you experienced any shortness of breath, fatigue, cough, ankle swelling?)
Timepoint [4] 450833 0
At enrolment

Eligibility
Key inclusion criteria
Inclusion criteria:

i. Adults (18 years and over)
ii. Currently taking an osteoporosis drug
iii. Must have had a DEXA scan
iv. Must have had a CTCA
v. The DEXA and CTCA must have occurred within 2 years of each other
vi. Participated in the original CAESAR study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

If the patient has any other medical conditions that may place them at risk after participating in this study (e.g. Pregnancy, vertigo, Parkinson’s disease) which may prevent the patient from remaining stationary and comfortable in a supine position - they will be excluded. Pregnancy status will be determined by asking the patient if they are currently pregnant, when their last menstrual period (LMP) was or completing a b-HCG urine test. If they are pregnant, they will be excluded. Whether vertigo or Parkinson’s may prevent the participant from imaging will be determined by the clinical judgement of the investigator and the radiographer completing the scans.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
30/05/2026
Actual
Sample size
Target
401
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319529 0
University
Name [1] 319529 0
School of Clinical Sciences at Monash Health, Monash University
Country [1] 319529 0
Australia
Primary sponsor type
University
Name
School of Clinical Sciences at Monash Health, Monash University
Address
Country
Australia
Secondary sponsor category [1] 322028 0
None
Name [1] 322028 0
Address [1] 322028 0
Country [1] 322028 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318103 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 318103 0
Ethics committee country [1] 318103 0
Australia
Date submitted for ethics approval [1] 318103 0
15/06/2025
Approval date [1] 318103 0
Ethics approval number [1] 318103 0

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

Contacts
Principal investigator
Name 143130 0
Prof Peter Ebeling
Address 143130 0
Level 5 Block E, Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168, Australia
Country 143130 0
Australia
Phone 143130 0
+61 3 85722570
Fax 143130 0
Email 143130 0
[email protected]
Contact person for public queries
Name 143131 0
Dr. Alexander Rodriguez
Address 143131 0
Level 5 Block E Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168, Australia
Country 143131 0
Australia
Phone 143131 0
+61 03 8572 2919
Fax 143131 0
Email 143131 0
[email protected]
Contact person for scientific queries
Name 143132 0
Dr. Alexander Rodriguez
Address 143132 0
Level 5 Block E Monash Medical Centre, 246 Clayton Road, Clayton, VIC 3168, Australia
Country 143132 0
Australia
Phone 143132 0
+61 432155802
Fax 143132 0
Email 143132 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: By contacting the principal (Prof. Peter Ebeling) or lead associate investigator (Dr. Alexander Rodriguez).

[email protected]
[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] CAESAR Protocol V2 20-7.docx


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.