Protocol Optimization in CT for the Quantification of BMD

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305156
• Other study ID #: CT_BMD_1
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: University of Zurich
• Contact: Hatem Alkadhi, MD, MPH
• Phone: +41 44 255 36 62
• Email: hatem.alkadhi[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Bone Loss
• Osteoporosis
• Osteoporosis, Osteopenia

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Diagnostic and Interventional Radiology, University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Hatem Alkadhi

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density CT	Bone mineral density derived from CT Scan	Immediately after CT scan of the participant.
Primary	Bone mineral density Dual-energy x-ray absorptiometry (DXA)	Bone mineral density derived from DXA Scan	Immediately after DXA scan of the participant.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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