Protocol Optimization in CT for the Quantification of BMD

Not Applicable

Recruiting

• Conditions: Osteoporosis, Osteopenia; Bone Loss
• Interventions: Diagnostic Test: Bone Mineral Density quantification

• Registration Number: NCT06305156
• Lead Sponsor: Hatem Alkadhi

Brief Summary

Bone mineral density is an important measurement to detect osteoporosis.

The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:

* How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA

* How can we optimize the CT scan for bone mineral density

Participants will undergo:

* Clinically indicated CT scan on day of inclusion

* Study related DXA scan on a separate appointment

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-12
• Study Start: 2024-03-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Informed Consent signed by the subject
• Referral to a regular clinically indicated CT examination covering the lumbar area (e.g., Abdomen, Thorax + Abdomen, Neck + Thorax +Abdomen)
• Informed written and oral consent (interpreter present in case of foreign language patients)
• No contraindication to the clinically indicated CT examination

Exclusion Criteria

• Patients < 18 years
• Pregnant women
• Vulnerable subjects
• Contraindications to the clinically indicated CT scan
• Multiple Myeloma
• Diffuse bone metastasis
• Fixateur interne in the lumbar spine
• Kyphoplasty in the lumbar spine
• Enterally administrated contrast agent
• Obtaining informed consent is not possible
• Withdrawal of consent orally or in writing
• Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject
• Immobility (patients confined to a wheelchair or to bed)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone mineral density CT vs DXA	Bone Mineral Density quantification	Single arm study, all participants receive CT and DXA.

Primary Outcome Measures

Name	Time	Method
Bone mineral density CT	Immediately after CT scan of the participant.	Bone mineral density derived from CT Scan
Bone mineral density Dual-energy x-ray absorptiometry (DXA)	Immediately after DXA scan of the participant.	Bone mineral density derived from DXA Scan

Secondary Outcome Measures

Name	Time	Method
Correlation between age and bone mineral density	1 year	Correlation analysis by means of linear regression and pearson correlation between age (in years) and bone mineral density
Correlation between weight and bone mineral density	1 year	Correlation analysis by means of linear regression and pearson correlation between weight and bone mineral density
Correlation between body mass index (BMI) and bone mineral density	1 year	Correlation analysis by means of linear regression and pearson correlation between body mass index (BMI, in kg/m\^2) and bone mineral density
Correlation between height and bone mineral density	1 year	Correlation analysis by means of linear regression and pearson correlation between height (in cm) and bone mineral density
Correlation between sex and bone mineral density	1 year	Correlation analysis by means of linear regression and pearson correlation between sex (male/female) and bone mineral density

Trial Locations

Locations (1)

Diagnostic and Interventional Radiology, University Hospital Zurich; 🇨🇭 Zürich, Switzerland