Management of Bone Metastases (OPTIMOS)

Civil Hospices of Lyon

Status: Active, not recruiting

Conditions: Cancer; Bone Metastases

Treatments: Other: Study of the treatment

Study type: Observational

Funder types: Other

Identifiers

NCT06713941

69HCL24_0905

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

900 participants in 1 patient group

Bone metatases

Description:

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

Treatment:

Other: Study of the treatment