Management of Bone Metastases

NCT06713941 | Active Not Recruiting

• 1 other identifier: 69HCL24_0905
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Bone Metastases

Keywords

Bone Metastases; bone target agent; medical care; international recommendation

Outcome Measures

Primary Outcomes (2)

• . 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.

Study Arms (1)

Bone metatases

This study involves adults with bone metastases or who have had a bone event associated with a cancer diagnosis.

Other: Study of the treatment

Interventions

Study of the treatment OTHER

Intervention Description 1 \* (Limit: 1000 characters) Study of prescribed treatments, treatments taken by the patients, and treatment discontinuation

Bone metatases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study involves adults with bone metastases or who have had a bone event associated with a cancer diagnosis being treated at the Hospices Civils de Lyon or the University Hospital of Brest.

You may qualify if:

• \-- Patients with an ICD 10 code for bone metastases: 79.5
• And/or patients having had a skeletal event (pathological fracture; spinal cord compression; malignant hypercalcemia; bone pain and preventive orthopedic surgery or spine surgery) associated with a diagnosis of oncological pathology
• Adult patients
• No opposition

You may not qualify if:

• Patients with a Long-Term Illiness (LTI) associated with a hospital diagnosis of Kaposi sarcoma over the same period as LTI
• Patient with a diagnosis of pathological fracture linked to a diagnosis of osteoporosis (M80)
• Patient under guardianship or curatorship
• Minor patients
• Patients not affiliated to the social security system at least 3 years before the diagnosis of MO and during the follow-up period.
• Patient already diagnosed with known bone metastases in the previous year.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Brest University Hospital

Brest, France, 29200, France

Location

Lyon Sud hospital, Hospices Civils de Lyon

Lyon, France, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: March 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

FR (2)