Osteoporotic FracturesBDATChileNCT05424536
Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical Measurement
An observational study of Osteoporotic Fractures, run by Universidad de Valparaiso at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporotic Fractures
- What is being tested?
- Bone measurement by DXA and ultrasound
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 18 Jul 2022to 31 Jan 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The cohort will be: Women and men over 50 years old
Who may be able to join
- > 50 years old
- Recent femoral bone fragility fracture
Who cannot join
- History of fracture
- Corticoid treatment
- Renal disease
- Arthritis
- BMI < 15 and > 30
- Double femoral prosthesis
- In case group/with fracture is added:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical
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.
Read the 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.
- Conditions
- Osteoporotic Fractures
- Being tested
- Bone measurement by DXA and ultrasound
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone measurement by DXA and ultrasoundOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical parameter measurement obtained by BDAT (Ultrasound)
Cortical thickness (mm) at one-third distal radius and mid-tibia
Measured: Inclusion time
Cortical parameter measurement obtained by BDAT (Ultrasound)
Cortical porosity (%) at one-third distal radius and mid-tibia
Measured: 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
Measured: 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
Measured: Inclusion time
Secondary outcomes (5)
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).
Measured: Inclusion time
femoral aBMD obtained by DXA
measurement of femoral areal Bone Mineral Density (aBMD g.cm-2).
Measured: Inclusion time
Body composition measurements obtained by DXA
body composition: body fat, muscle and bone mass (kg).
Measured: Inclusion time
10-year probability of fracture provided by FRAX algotithm
10-year probability of a major osteoporotic fracture, calculated with the femoral aBMD value.
Measured: Inclusion time
10-year probability of fracture provided by FRAX algotithm
10-year probability of a major osteoporotic fracture, calculated without the femoral aBMD value.
Measured: Inclusion time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start18 Jul 2022
- Primary completion24 Jan 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporotic FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Valparaiso, Centro Gerópolis UV, Valparaíso, Centro de Salud Familiar Marcelo Mena, Hospital Dr. Gustavo Fricke, Valparaíso
- Responsible party
- Sponsor
- Investigators
- Jean-Gabriel Minonzio, Ph.D, Principal investigator, Universidad de ValparaisoJosé Luis Dinamarca, M.D., Study chair, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424536
- Sponsor's protocol ID
- 1201311
- Acronym
- BDATChile
- Status last verified
- Jan 2023
- First submitted
- 14 Jun 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dubot B, Deniau M, Ramiandrisoa D, Minonzio JG. Cortical Bone Assessment Using Ultrasonic Guided Waves: A Reproducibility Study in a Healthy Population. J Vis Exp. 2025 Jan 31;(215). doi: 10.3791/66985.
PubMed 39960164
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Bone Assessment Using Ultrasonic Guided Waves: Towards a Robust Clinical
- ClinicalTrials.gov ID
- NCT05424536
- Acronym / sponsor ID
- BDATChile / 1201311
- Conditions
- Osteoporotic Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Valparaiso, Centro Gerópolis UV, Valparaíso, Centro de Salud Familiar Marcelo Mena, Hospital Dr. Gustavo Fricke, Valparaíso
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be: Women and men over 50 years old
Key inclusion criteria (2 listed)
- > 50 years old
- Recent femoral bone fragility fracture
Key exclusion criteria (7 listed)
- History of fracture
- Corticoid treatment
- Renal disease
- Arthritis
- BMI < 15 and > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone measurement by DXA and ultrasoundMeasurement 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. | Other | – |
Primary outcome
Cortical parameter measurement obtained by BDAT (Ultrasound)
Time frame: Inclusion time
Cortical thickness (mm) at one-third distal radius and mid-tibia
Cortical parameter measurement obtained by BDAT (Ultrasound)
Time frame: Inclusion time
Cortical porosity (%) at one-third distal radius and mid-tibia
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
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
5 secondary outcomes
Quality measurement parameter obtained by BDAT (Ultrasound)
Time frame: Inclusion time
femoral aBMD obtained by DXA
Time frame: Inclusion time
Body composition measurements obtained by DXA
Time frame: Inclusion time
10-year probability of fracture provided by FRAX algotithm
Time frame: Inclusion time
10-year probability of fracture provided by FRAX algotithm
Time frame: Inclusion time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 39960164Dubot B, Deniau M, Ramiandrisoa D, Minonzio JG. Cortical Bone Assessment Using Ultrasonic Guided Waves: A Reproducibility Study in a Healthy Population. J Vis Exp. 2025 Jan 31;(215). doi: 10.3791/66985.
- study using the same ultrasonic deviceLink provided by the sponsor.
- The FRAX® algorithms give the 10-year probability of fracture.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Gabriel Minonzio, Ph.D principal investigator
Universidad de Valparaiso
José Luis Dinamarca, M.D. study chair
Universidad de Valparaiso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporotic Fractures, run by Universidad de Valparaiso at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical parameter measurement obtained by BDAT (Ultrasound) (time frame: Inclusion time). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05424536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.