Protocol Optimization in CT for the Quantification of BMD

NCT06305156 | Completed

• 1 other identifier: CT_BMD_1
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis, Osteopenia; Bone Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Correlation between age and bone mineral density

  1 year

• Correlation between sex and bone mineral density

  1 year

• Correlation between height and bone mineral density

  1 year

• Correlation between weight and bone mineral density

  1 year

• Correlation between body mass index (BMI) and bone mineral density

  1 year

Study Arms (1)

Bone mineral density CT vs DXA

OTHER

Single arm study, all participants receive CT and DXA.

Diagnostic Test: Bone Mineral Density quantification

Interventions

Bone Mineral Density quantification DIAGNOSTIC_TEST

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.

Bone mineral density CT vs DXA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hatem Alkadhi: lead

Study Sites (1)

Diagnostic and Interventional Radiology, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hatem Alkadhi, MD, MPH

  Diagnostic and Interventional Radiology, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Attending Physician, Vice Director of the Institute, Institute for Diagnostic and Interventional Radiology

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 12, 2024
• Study Start: March 13, 2024
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)