Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical Measurement

Osteoporotic Fractures Clinical Trial

— BDATChile  

Official title:

Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424536
• Other study ID #: 1201311
• Status: Recruiting
• Start date: July 18, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2023
• Source: Universidad de Valparaiso
• Contact: Jean-Gabriel Minonzio, Ph.D
• Phone: +56 3 22 60 37 38
• Email: jean-gabriel.minonzio[@]uv.cl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Osteoporosis is a skeletal disease leading to bone fragility and increasing the risk of fractures and still remains a major public health problem worldwide. Therefore it is crucial to prevent severe fractures responsible for excess of mortality and considerable morbidity. Patient at risk of fractures are currently identified as having osteoporosis using Dual-energy X-ray Absorptiometry (DXA), assessing the areal or projected Bone Mineral Density (aBMD g.cm-2). In Chile, the hip fracture occurrence is very similar to the international incidence. Due to the demographic and epidemiological transition, the number of hip fracture for patient older than 50 year, is expected to severely increase from about 6.500 (2007) to 30.000 (2050) without adequate preventive and / or therapeutic measures.

Even if DXA remains the current gold standard, it is limited by the difficulty to set a threshold in the BMD distribution for osteoporosis diagnosis. Moreover, some medical conditions (chronic kidney disease, diabetes) or drugs (glucocorticoids) are associated with an increase of fracture risk without a BMD decrease. Quantitative ultrasound (QUS) have the advantages of portability, low cost, absence of radiation and need for a radiographic technologist or designated room, and are sensitive to both elasticity and geometry of the medium explored by the waves. Among QUS techniques, axial transmission (AT) is a technique for which transducers are aligned along the bone axis. Measured ultrasonic guided waves, associated with an appropriate waveguide model have the potential to yield estimates of material and/or geometrical cortical properties. In vivo combined estimation of both cortical thickness and porosity has been proposed using bidirectional axial transmission (BDAT). BDAT measurement has been recently validated on ex vivo specimen (radius and tibia) and has been tested in a pilot clinical study, in which cortical porosity measured at the one-third distal radius has been found as discriminant of low trauma fractures as DXA. Cortical porosity is increasingly recognized as a major contributor to bone fragility.

The hypothesis underlying this project are that (1) it is possible to obtain robust and accurate estimates of cortical thickness and porosity using an improved BDAT device and (2) these estimates are of clinical interest in the context of osteoporosis in elderly. Moreover, novel parameters obtained from automatic classification tools will be tested.

Description:

The purpose of this investigation is to determine if there are differences in the quantities of cortical bone (thickness and porosity) as well as the new parameters measured by BDAT at both forearm and leg, between patients with recent non traumatic fracture and controls.

Results will be compared to the current gold standard dual-energy X-ray absorptiometry (DXA) of the hip, spine and forearm, obtained from all subjects. The BDAT device with the improved interface will be tested in a clinical environment by clinical operators on:

• minimum sample size per group: 25 for cases and controls (female and male, over 50 years).

• Fractured patients will be obtained at the traumatology service of Fricke Hospital (Viña del Mar) which receives about 350 patients with hip fractures per year.

• Control will be obtained at the community health centers of Valparaiso in collaboration with the UV project Geropolis.

DXA measurement will be done at the imaging center of the Universidad Catolica de Valparaiso (PUCV, FONDEQUIP EQM160142). Additional DXA parameters concerning muscle and fat, will be taken into account.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2024
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

For both groups:

Inclusion Criteria:

• > 50 years old

Exclusion Criteria:

• History of fracture

• Corticoid treatment

• Renal disease

• Arthritis

• BMI < 15 and > 30

• Double femoral prosthesis

In case group/with fracture is added:

Inclusion criteria

• Recent femoral bone fragility fracture

Related Conditions & MeSH terms

• Osteoporotic Fractures

Intervention

Other:
• Bone measurement by DXA and ultrasound
Measurement will be performed at radius and at tibia (ultra-distal and distal). For all the sites plus femoral neck, one measurement will be performed by DXA to get reference values of thickness and BMDs. For the distal positions and additional measurement will be performed by an innovative ultrasound device that estimates cortical thickness and porosity.

Locations

Country	Name	City	State
Chile	Universidad de Valparaíso	Valparaíso

Sponsors (5)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Centro de Salud Familiar Marcelo Mena, Centro Gerópolis UV, Valparaíso, Hospital Dr. Gustavo Fricke, Valparaíso, Pontificia Universidad Catolica de Valparaiso

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical parameter measurement obtained by BDAT (Ultrasound)	Cortical thickness (mm) at one-third distal radius and mid-tibia	Inclusion time
Primary	Cortical parameter measurement obtained by BDAT (Ultrasound)	Cortical porosity (%) at one-third distal radius and mid-tibia	Inclusion time
Primary	Ultrasonic velocities measurement obtained by BDAT (Ultrasound)	velocity (m.s-1) of the First Arriving Signal (VFAS) at one-third distal radius and mid-tibia	Inclusion time
Primary	Ultrasonic velocities measurement obtained by BDAT (Ultrasound)	velocity (m.s-1) of the A0 guided mode (A0) at one-third distal radius and mid-tibia	Inclusion time
Secondary	Quality measurement parameter obtained by BDAT (Ultrasound)	measurement at one-third distal radius and mid-tibia, normalized quality parameter (value ranging from 0 to 1).	Inclusion time
Secondary	femoral aBMD obtained by DXA	measurement of femoral areal Bone Mineral Density (aBMD g.cm-2).	Inclusion time
Secondary	Body composition measurements obtained by DXA	body composition: body fat, muscle and bone mass (kg).	Inclusion time
Secondary	10-year probability of fracture provided by FRAX algotithm	10-year probability of a major osteoporotic fracture, calculated with the femoral aBMD value.	Inclusion time
Secondary	10-year probability of fracture provided by FRAX algotithm	10-year probability of a major osteoporotic fracture, calculated without the femoral aBMD value.	Inclusion time

External Links

•   study using the same ultrasonic device
•   study using the same ultrasonic device
•   The FRAX® algorithms give the 10-year probability of fracture.