umerical simulation and in-vivo detection of microstructural changes in cortical bone using high-frequency ultrasonic backscatter

• Conditions: M81.9; M85.9; Osteoporosis, unspecified; Disorder of bone density and structure, unspecified

• Registration Number: DRKS00022217
• Lead Sponsor: Charité Campus Benjamin Franklin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-03
• Study Completion: 2020-08-07
• Results First Posted: 2021-09-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

(i) women >55 years of age; (ii) written informed consent to participate in the study (patient consent); (iii) DXA BMD proximal femur or lumbar spine T-score < -1.0

Exclusion Criteria

(i) BMI > 30; (ii) oedema, metal implants or paralysis of the lower limb to be measured; (iii) participants who are unable to undergo the examinations required by the protocol or who have cognitive limitations that preclude understanding the study protocol.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The correlations of the cortical pore size with the numerically and experimentally derived backscatter parameters are comparable.

Secondary Outcome Measures

Name	Time	Method
The cortical thickness and microstructure parameters (bone mineral density distribution, porosity, number and size of pores) derived from the HR-pQCT data are comparable to the parameters (porosity, pore size) determined from the CortBS analysis.