NCT06545487

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 5, 2024

Last Update Submit

August 7, 2024

Conditions

Osteoporosis RiskFracture of FemurFragility

Outcome Measures

Primary Outcomes (2)

  • Comparison between parameters intra-groups

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

    2023-2024

  • Comparison between parameters inter-groups

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

    2023-2024

Study Arms (2)

CONTROL

Other: BLOOD SAMPLE

FRACTURA

Other: BLOOD SAMPLE

Interventions

BLOOD SAMPLEOTHER

BLOOD ANALYTICS IN SEVERAL PARAMETERS

CONTROLFRACTURA

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly population over 60 years old

You may qualify if:

  • minimum 60 years

You may not qualify if:

  • Hip fractures
  • unable to walk from point of examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Valparaíso

Valparaíso, Chile

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

BLOOD SAMPLE

MeSH Terms

Conditions

Femoral Fractures

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 9, 2024

Study Start

March 5, 2024

Primary Completion

April 9, 2024

Study Completion

April 9, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)