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Osteoporosis RiskNCT06545487

Prediction Model of Hip Fragility Fracture Realistic Data From a Traumatology Department and Orthogeriatric Ward.

An observational study of Osteoporosis Risk and Fracture of Femur, run by Universidad de Valparaiso at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the project is to build a prediction model of hip fragility fracture using hospital data routinely collected in the traumatology department from the last 12 years and up to date Explainable Artificial Intelligence (XAI) tools. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Osteoporosis Risk, Fracture of Femur, Fragility
What is being tested?
BLOOD SAMPLE
How many people
50 participants
Where
1 siteChile
Study dates
5 Mar 2024to 9 Apr 2024
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Elderly population over 60 years old

Who may be able to join

  • minimum 60 years

Who cannot join

  • Hip fractures
  • unable to walk from point of examination

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Universidad de Valparaíso

    Valparaíso

Other trials in Chile

About this study

Official title: Prediction Model of Hip Fragility Fracture Using Explainable Artificial Intelligence and Realistic Data From a Traumatology Department and Orthogeriatric Ward

The aim of the project is to build a prediction model of hip fragility fracture using hospital data routinely collected in the traumatology department from the last 12 years and up to date Explainable Artificial Intelligence (XAI) tools. This model should be adapted to the "real world" conditions of the region and predict clinical data such as risk of fracture and refracture, mortality risk, fracture type classification and the generation of a specific comorbidity index.

Read the detailed description

Osteoporosis and associated fragility fractures remain an increasing worldwide burden for both health systems and families, in the context of ageing populations. Hip fractures are particularly severe due to the hospital stay, operations, arduous recovery and risk of subsequent fractures.

Thus, it is of significant importance to detect patients at high risk of femoral fragility fractures and to anticipate their recovery capacities in order to take appropriate medical decisions. Early detection of bone deterioration would be ideal for better prevention and bone reconstruction.

The current gold standard for osteoporosis remains the Dual-energy X-ray absorptiometry (DXA),however one the one hand, a majority of fractured patients are not classified as osteoporotic using the WMO definition and on the other hand, DXA is not widely available in numerous places.

Different alternative devices, such as 3D X-Rays, MRI or ultrasound, with different costs and availability, have been proposed. Moreover, online forms, such as FRAX, Garvan or Qfracture, propose to calculate the fracture risk from a limited number of clinical factors.

Nowadays, growing accessibility to clinical data, processing methods and computing power, opened the way to novel data driven prediction models using a large number of biomarkers or parameters, opening perspective towards personalised precision medicine. However a few challenges arise:

  1. the data availability and quality to build the models,
  2. the ability to collect realistic data from new patients in agreement with the cost and possibilities of each country and
  3. the determination of the most important parameters in order to help medical decisions in an interpretable way.

The aim of the project is to build a prediction model of hip fragility fracture using available hospital data, routinely collected in the traumatology department and orthogeriatric ward from the last 12 years, data to be acquired of a control group (without fragility fracture) and up to date Explainable Artificial Intelligence (XAI) tools. This model should be adapted to the "real world" conditions of the region and predict clinical data such as risk of fracture and refracture, mortality risk, fracture type classification and the generation of a specific comorbidity index. Special attention will be given to potential early detectors of bone fragility.

Moreover, this model would later include alternative DXA measurements such as ultrasound, using a specific device successfully tested by the same team. It could also be afterwards compared to other countries or regions with similar available data, thanks to international colleagues currently collaborating with the team. In case of success, database format and prediction models could be shared with other hospitals with perspectives of progressive national and international scaling. In the near future this information could be translated into an informatics tool that could help the physician in his clinical following of the older patients.

Being tested
BLOOD SAMPLE
Medical subject headings
Femoral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BLOOD SAMPLEOther

    BLOOD ANALYTICS IN SEVERAL PARAMETERS

Study groups in NCT06545487
Study groupRoleWhat they receive
CONTROLNot described
Receives: Other: BLOOD SAMPLE
FRACTURANot described
Receives: Other: BLOOD SAMPLE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison between parameters intra-groups

    Analysis of data extracted from blood samples comparing data in control and fractured group separatedly

    Measured: 2023-2024

  2. Comparison between parameters inter-groups

    Analysis of data extracted from blood samples comparing data in control and fractured groups

    Measured: 2023-2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start5 Mar 2024
  3. Primary completion9 Apr 2024
  4. Study completion9 Apr 2024

Resources

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
Other
Time perspective
Retrospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06545487
Sponsor's protocol ID
NAM23|0059
Status last verified
Aug 2024
First submitted
5 Aug 2024
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoporosis Risk and Fracture of Femur, 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 1 inclusion and 2 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 9 Aug 2024. 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?

Comparison between parameters intra-groups (time frame: 2023-2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Aug 2024.

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