Management of Bone Metastases

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Bone Metastases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brest University Hospital, Brest, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Study of the treatment

Other

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

Primary outcomes

. 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.

Time frame: Through study completion maximum 1 year.
Age at diagnosis, age at inclusion, sex.

Time frame: Through study completion maximum 1 year.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Study of the Management of Bone Metastases Compared to National Recommendations

Acronym: OPTIMOS

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Dec 3, 2024
Registry last updated: Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting