Clinical trial NCT05424536: Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical Measurement
Official title: Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporotic Fractures
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica de Valparaiso
name: Centro Gerópolis UV, Valparaíso
name: Centro de Salud Familiar Marcelo Mena
name: Hospital Dr. Gustavo Fricke, Valparaíso
First posted: 2022-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort will be:

Women and men over 50 years old

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cortical parameter measurement obtained by BDAT (Ultrasound)
timeFrame: Inclusion time
measure: Cortical parameter measurement obtained by BDAT (Ultrasound)
timeFrame: Inclusion time
measure: Ultrasonic velocities measurement obtained by BDAT (Ultrasound)
timeFrame: Inclusion time
measure: Ultrasonic velocities measurement obtained by BDAT (Ultrasound)
timeFrame: Inclusion time
Secondary outcomes:
measure: Quality measurement parameter obtained by BDAT (Ultrasound)
timeFrame: Inclusion time
measure: femoral aBMD obtained by DXA
timeFrame: Inclusion time
measure: Body composition measurements obtained by DXA
timeFrame: Inclusion time
measure: 10-year probability of fracture provided by FRAX algotithm
timeFrame: Inclusion time
measure: 10-year probability of fracture provided by FRAX algotithm
timeFrame: Inclusion time
Other outcomes:
Locations:
city: Valparaíso
country: Chile
facility: Universidad de Valparaíso
Study officials:
affiliation: Universidad de Valparaiso
name: Jean-Gabriel Minonzio, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Valparaiso
name: José Luis Dinamarca, M.D.
role: STUDY_CHAIR
References: