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Completed

NCT Number: NCT05424536

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad de Valparaíso

Valparaíso, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone measurement by DXA and ultrasound

Other

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.

Primary outcomes

  1. Cortical parameter measurement obtained by BDAT (Ultrasound)

    Time frame: Inclusion time

    Cortical thickness (mm) at one-third distal radius and mid-tibia

  2. Cortical parameter measurement obtained by BDAT (Ultrasound)

    Time frame: Inclusion time

    Cortical porosity (%) at one-third distal radius and mid-tibia

  3. Ultrasonic velocities measurement obtained by BDAT (Ultrasound)

    Time frame: Inclusion time

    velocity (m.s-1) of the First Arriving Signal (VFAS) at one-third distal radius and mid-tibia

  4. Ultrasonic velocities measurement obtained by BDAT (Ultrasound)

    Time frame: Inclusion time

    velocity (m.s-1) of the A0 guided mode (A0) at one-third distal radius and mid-tibia

Secondary outcomes

  1. Quality measurement parameter obtained by BDAT (Ultrasound)

    Time frame: Inclusion time

    measurement at one-third distal radius and mid-tibia, normalized quality parameter (value ranging from 0 to 1).

  2. femoral aBMD obtained by DXA

    Time frame: Inclusion time

    measurement of femoral areal Bone Mineral Density (aBMD g.cm-2).

  3. Body composition measurements obtained by DXA

    Time frame: Inclusion time

    body composition: body fat, muscle and bone mass (kg).

  4. 10-year probability of fracture provided by FRAX algotithm

    Time frame: Inclusion time

    10-year probability of a major osteoporotic fracture, calculated with the femoral aBMD value.

  5. 10-year probability of fracture provided by FRAX algotithm

    Time frame: Inclusion time

    10-year probability of a major osteoporotic fracture, calculated without the femoral aBMD value.

Sponsors and collaborators

Lead sponsor

Universidad de Valparaiso

Other

Collaborators

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

Registry information

Official study title

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

Acronym: BDATChile

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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