Fracture Risk Evaluation of Bone Metastases Derived From Carcinoma

December 12, 2025 updated by: Costantino Errani

Generation of Synthetic Patient Data (RAW) for Risk Evaluation of Bone Metastases Derived From Carcinoma

From the archives of the Rizzoli institute all patients (approximately 750) treated for bone metastases from 01/01/2010 to 31/12/2022.

A review will be made from the medical records, radiological imaging, and histological data of these patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Male and female adult patients, affected by bone metastases derived from carcinoma, treated at Rizzoli Ortopaedic institute from 01/01/2010 to 31/12/2022.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosis of bone metastasis from carcinoma, regardless of the type of carcinoma, and of the number and location of the metastases
  • Availability of imaging and clinical data
  • Availability of at least one follow-up during the last 12 months form diagnosis

Exclusion Criteria:

  • At least one inclusion creteria not met

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Male and female patients affected by bone metastases derived from carcinoma, treated at Rizzoli Orthopaedic Institute from 01/01/2010 to 31/12/2022
Other: Analysis
Analysis and review of imaging and clinical data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creation a dataset of clinical data and diagnostic images
Time Frame: At baseline (Day 0)
Creation a dataset of clinical data and diagnostic images, called RAW, relating to patients suffering from metastatic bone cancer that will be used by the unit UNICH to create innovative models for fracture risk prediction and of life expectancy based on various patient clinical parameters.
At baseline (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Costantino Errani

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRAIL-RAW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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