Protocol Optimization in CT for the Quantification of BMD

Protocol-optimization in Computed Tomography for the Quantification of Bone Mineral Density (BMD)

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

Study Overview

• Status: Completed
• Conditions: Bone Loss; Osteoporosis, Osteopenia
• Intervention / Treatment: Diagnostic test: Bone Mineral Density quantification

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • Diagnostic and Interventional Radiology, University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bone mineral density CT vs DXA; Single arm study, all participants receive CT and DXA.	Diagnostic test: Bone Mineral Density quantification; In the first visit, participants receive clinically indicated CT scan, where bone mineral density will be derived. In a second, study related visit, participants will receive a DXA scan for bone mineral quantifications.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hatem Alkadhi
• Investigators: Principal Investigator: Hatem Alkadhi, MD, MPH, Diagnostic and Interventional Radiology, University Hospital Zurich

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Actual): December 19, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Osteoporosis; Bone Diseases, Metabolic
• Other Study ID Numbers: CT_BMD_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No