Identification of increased fracture risk through non-invasive determination of cortical micro- and macro-structural properties using quantitative bone ultrasound imaging

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025849

Enrollment

150

Registered

2021-07-14

Start date

2021-11-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M80 M85

Interventions

Group 1: Participants over 55 years of age with presumably reduced bone density and fragility fractures. Single ultrasound measurement of the tibia + questionnaire on risk factors for osteoporosis / f

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: For all study participants: - written informed consent to participate in the study. For patients: - Age:> 55 years - Guideline-compliant bone mineral density measurement For healthy subjects: - Age: 18 - 50 years

Exclusion criteria

Exclusion criteria: - BMI> 30 - Edema on the lower extremity to be measured - Metal implants on the lower extremity to be measured - Paralysis of the lower extremity to be measured - Participants who are unable to undergo the examinations prescribed in the protocol or who have cognitive impairments that preclude understanding of the study protocol.

Design outcomes

Primary

Measure	Time frame
The discrimination performance for fragility fractures is better for QUSIB biomarkers than for DXA-based T-scores. Using Partial Least Squares (PLS) regression and discrimination analyzes, associations between the multivariate biomarkers (ultrasound and clinically indicated DXA bone mineral density measurement) are examined and the parameters that make the greatest contribution to fracture discrimination are determined. Age, BMI, gender and drugs that affect bone metabolism are taken into account as covariates. In particular, the discrimination performance of X-ray and US-based parameters and their combination in terms of correctness, sensitivity and specificity are compared with each other with the help of an ROC analysis and determination of the area-under-the-curve (AUC) (Arm 1 and 2)	—

Measure

Time frame

The discrimination performance for fragility fractures is better for QUSIB biomarkers than for DXA-based T-scores. Using Partial Least Squares (PLS) regression and discrimination analyzes, associations between the multivariate biomarkers (ultrasound and clinically indicated DXA bone mineral density measurement) are examined and the parameters that make the greatest contribution to fracture discrimination are determined. Age, BMI, gender and drugs that affect bone metabolism are taken into account as covariates. In particular, the discrimination performance of X-ray and US-based parameters and their combination in terms of correctness, sensitivity and specificity are compared with each other with the help of an ROC analysis and determination of the area-under-the-curve (AUC) (Arm 1 and 2)

—

Secondary

Measure	Time frame
The QUSIB biomarkers and the discrimination thresholds derived from them are age and gender dependent.	—

Countries

Germany

Contacts

Public ContactGabriele Armbrecht

Charite - Universitätsmedizin Berlin, Campus Benjamin Franklin

gabi.armbrecht@charite.de+49 30 450527485

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026