Management of Bone Metastases

Active, not recruiting

• Conditions: Cancer; Bone Metastases

• Registration Number: NCT06713941
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Bone metastases (BM) are responsible for various bone events such as pathological fractures, spinal cord compression, preventive bone surgery, and severe bone pain requiring palliative radiotherapy management. Bone-targeted treatments, such as DENOSUMAB and bisphosphonates, are approved for preventing bone events caused by BM in patients being treated for metastatic cancer.

Clinical research on solid tumors has shown a reduction in the incidence of bone events with these treatments. Given this demonstrated effectiveness, it is important to optimize patient management by studying the characteristics of treated versus untreated patients, the incidence of bone events, and the impact of these events on patients.

A first nationwide study using EGB data (1/97th of the population) showed a low rate of management with bone-targeted treatment. Only 9% of patients with BM or a bone event associated with a cancer diagnosis received bone-targeted treatment. To validate and refine these results, we aim to replicate the protocol at Lyon Sud Hospital. Indeed, a greater amount of information will be available to answer the research question, and a number of biases can be avoided.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-15
• Status Verified: 2024-11
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
. Clinical description: age at diagnosis, number of patients experiencing a bone event, number and types of comorbidities at the time of diagnosis per patient, vital status at inclusion, and date of death.	Through study completion maximum 1 year.
Age at diagnosis, age at inclusion, sex.	Through study completion maximum 1 year.

Trial Locations

Locations (2)

Brest University Hospital; 🇫🇷 Brest, France

Lyon Sud hospital, Hospices Civils de Lyon; 🇫🇷 Lyon, France