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Management of Bone Metastases

Study of the Management of Bone Metastases Compared to National Recommendations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06713941
Acronym
OPTIMOS
Enrollment
900
Registered
2024-12-03
Start date
2024-03-15
Completion date
2025-07-01
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Cancer

Keywords

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

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.

Interventions

OTHERStudy of the treatment

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026