Management of Bone Metastases

NCT ID: NCT06713941

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Bone Metastases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bone metatases

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

Study of the treatment

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Study of the treatment

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-- 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

Exclusion Criteria

* \- Patient hospitalized for a sarcoma during the pre-inclusion period and inclusion
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brest University Hospital

Brest, France, France

Site Status

Lyon Sud hospital, Hospices Civils de Lyon

Lyon, France, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

69HCL24_0905

Identifier Type: -

Identifier Source: org_study_id