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

NCT05424536 | Completed

• 1 other identifier: 1201311
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporotic Fractures

Outcome Measures

Primary Outcomes (4)

• Cortical parameter measurement obtained by BDAT (Ultrasound)

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

  Inclusion time

• Cortical parameter measurement obtained by BDAT (Ultrasound)

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

  Inclusion time

• 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

• 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 Outcomes (5)

• Quality measurement parameter obtained by BDAT (Ultrasound)

  Inclusion time

• femoral aBMD obtained by DXA

  Inclusion time

• Body composition measurements obtained by DXA

  Inclusion time

• 10-year probability of fracture provided by FRAX algotithm

  Inclusion time

• 10-year probability of fracture provided by FRAX algotithm

  Inclusion time

Interventions

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort will be: Women and men over 50 years old

You may qualify if:

• \> 50 years old

You may not qualify if:

• History of fracture
• Corticoid treatment
• Renal disease
• Arthritis
• BMI \< 15 and \> 30
• Double femoral prosthesis
• In case group/with fracture is added:
• Recent femoral bone fragility fracture

Sponsors & Collaborators

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

Study Sites (1)

Universidad de Valparaíso

Valparaíso, Chile

Location

Related Links

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

MeSH Terms

Conditions

Osteoporotic Fractures

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Jean-Gabriel Minonzio, Ph.D

  Universidad de Valparaiso

  PRINCIPAL INVESTIGATOR

• José Luis Dinamarca, M.D.

  Universidad de Valparaiso

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: July 18, 2022
• Primary Completion: January 24, 2023
• Study Completion: January 31, 2024
• Last Updated: January 16, 2026

Record last verified: 2023-01

Locations

CL (1)