Management of Bone Metastases (OPTIMOS)

Study of the Management of Bone Metastases Compared to National Recommendations

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Bone Metastases
• Intervention / Treatment: Other: Study of the treatment

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

Study Locations

• France
  • Brest, France, 29200
    • Brest University Hospital
  • Lyon, France
    • Lyon Sud hospital, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Intervention Description 1 * (Limit: 1000 characters) Study of prescribed treatments, treatments taken by the patients, and treatment discontinuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
. 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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Bone Metastases; bone target agent; medical care; international recommendation
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Hematologic Diseases; Neoplastic Processes; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
• Other Study ID Numbers: 69HCL24_0905

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No