Fracture Risk Evaluation of Bone Metastases Derived From Carcinoma

NCT06524843 | Recruiting

• 1 other identifier: FRAIL-RAW
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Metastases

Keywords

Bone metastases; Prediction model

Outcome Measures

Primary Outcomes (1)

• Creation a dataset of clinical data and diagnostic images

  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)

Study Arms (1)

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

Interventions

Analysis OTHER

Analysis and review of imaging and clinical data

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Costantino Errani: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40134, Italy

RECRUITING

Related Publications (2)

• Mirels H. Metastatic disease in long bones: A proposed scoring system for diagnosing impending pathologic fractures. 1989. Clin Orthop Relat Res. 2003 Oct;(415 Suppl):S4-13. doi: 10.1097/01.blo.0000093045.56370.dd.

  PMID: 14600587 BACKGROUND

• Coleman RE. Clinical features of metastatic bone disease and risk of skeletal morbidity. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6243s-6249s. doi: 10.1158/1078-0432.CCR-06-0931.

  PMID: 17062708 BACKGROUND

Central Study Contacts

Costantino Errani, MD

CONTACT

0516366; costantino.errani@ior.it

Roberta Laranga, PhD

CONTACT

051636; roberta.laranga@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

IT (1)