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Coronary Artery Stenosis in Anti-Resorptive Users (CAESAR) Imaging Study

Coronary Artery Stenosis in Anti-Resorptive Users adults with osteoporosis (CAESAR) Imaging Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000955415
Enrollment
401
Registered
2025-09-01
Start date
2025-09-30
Completion date
2025-10-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a follow-up to the original CAESAR study to further establish a stronger relationship between coronary artery calcification (CAC) and osteoporosis with the use several scans. It involves a two-part set-up, including an invitation for patients to return for a questionnaire to be asked in-person, and a comprehensive skeletal and cardiovascular assessment. The aim of this study is to identify pre-existing or new comorbidities for the patient group, medication compliance and patient well-being. Additionally, we aim to re-establish the effectiveness of anti-resorptive treatment and side-effect profile of these medications, whilst also establishing a correlation between changes in CAC score over time and changes in bone mineral density (BMD) over time. It is hypothesised that CAC may alter the efficacy of anti-resorptive therapy in patients with osteoporosis due to shared metabolic pathways, and that due to poor efficacy of these drugs, different therapies such as an anabolic therapy may be more effective.

Interventions

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 miner

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.

Sponsors

School of Clinical Sciences at Monash Health, Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026