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CompletedNCT06545487Updated Aug 9, 2024

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

An observational study in Osteoporosis Risk, Fracture of Femur and Fragility, sponsored by Universidad de Valparaiso. Completed at 1 site in Chile. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by Universidad de Valparaiso · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
50
Ages
60 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Osteoporosis Risk
  • Fracture of Femur
  • Fragility

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03

In context

Femoral Fractures

186 studies on the registry are indexed under Femoral Fractures; 38 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 67 observational studies indexed under Femoral Fractures.

Browse Femoral Fractures studies →

Lead sponsor

Universidad de Valparaiso is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Elderly population over 60 years old

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • minimum 60 years

Exclusion criteria

Exclusion Criteria:

  • Hip fractures
  • unable to walk from point of examination
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • CONTROL

    Other: BLOOD SAMPLE

  • FRACTURA

    Other: BLOOD SAMPLE

Interventions

  • OtherBLOOD SAMPLE

    BLOOD ANALYTICS IN SEVERAL PARAMETERS

06

What researchers measure

Primary outcomes

  1. Comparison between parameters intra-groups

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

    Time frame: 2023-2024

  2. Comparison between parameters inter-groups

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

    Time frame: 2023-2024

07

Study locations

1 site
  • Universidad de Valparaíso
    Valparaíso, Chile
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06545487
Lead sponsor
Universidad de Valparaiso
Collaborators
HOSPITAL DOCTOR GUSTAVO FRICKE, Centro Interdisciplinario para el Desarrollo del Adulto Mayor Gerópolis
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Mar 5, 2024
Primary completion
Apr 9, 2024
Completion
Apr 9, 2024
Last update
Aug 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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