Pore size distribution and viscoelastic attenuation - new ultrasound-based biomarkers to assess fracture risk in patients with diabetes mellitus.

Pore size distribution and viscoelastic attenuation - new ultrasound-based biomarkers to assess fracture risk in patients with diabetes mellitus. - DIABETOPORE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029331

Enrollment

Registered

2023-04-06

Start date

2022-11-03

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

E10

Interventions

Group 1: Patients with diabetes mellitus type 1 or type 2 AND past fragility fractures: A single measurement of microstructural bone structures at the tibia is performed using a medical ultrasound sca

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: - Female and male patients between 50 - 80 years - patients with a diagnosis of diabetes (type 1 or type 2) with or without previous fragility fractures - capability to understand the patient information and consent to participation in the project and storage of data - patients who have receivied a Dual-Energy-Absorptiometry (DXA) measurement (not older than 6 months)

Exclusion criteria

Exclusion criteria: - BMI > 35 - Edema at the measurement site - metal implants at the measurement site - palsy at the measurement site - patients incapable of giving informed consent for any reason - prisoners and all persons who are committed to an institution due to an official or judicial order

Design outcomes

Primary

Measure	Time frame
Regression and discriminant analyses will be used to examine associations between multivariate (BMD, TBS, US) biomarkers and identify parameters that contribute most to fracture discrimination. Age, BMI, gender, diabetes type, and antidiabetic therapy and other risk factors will be considered as covariate variables. Specifically, the discriminatory performance of radiographic and US-based parameters and their combination for vertebral and other fragility fractures will be compared in terms of accuracy, sensitivity, and specificity using ROC- analysis and area-under-the-curve (AUC) determination.	—

Measure

Time frame

Regression and discriminant analyses will be used to examine associations between multivariate (BMD, TBS, US) biomarkers and identify parameters that contribute most to fracture discrimination. Age, BMI, gender, diabetes type, and antidiabetic therapy and other risk factors will be considered as covariate variables. Specifically, the discriminatory performance of radiographic and US-based parameters and their combination for vertebral and other fragility fractures will be compared in terms of accuracy, sensitivity, and specificity using ROC- analysis and area-under-the-curve (AUC) determination.

—

Secondary

Measure	Time frame
- impact of antidiabetic therapy on cortical porosity - difference in cortical porosity between male and female patients - impact of diabetes-specific variables (HbA1c, AGEs, HOMA-IR) on kortikal microarchitecture - discriminatory capablitiy of cortical ultrasound for fractures according to fracture site	—

Countries

Germany

Contacts

Public ContactEdgar Wiebe

Med. Klinik m.SP. Rheumatologie und Klinische Immunologie, Charité Universitätsmedizin Berlin

edgar.wiebe@charite.de+49 (0) 30 450 513399

Outcome results

None listed

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