ZOLEDRONIC ACID MONOHYDRATE for Vertebral metastases | Metastatic bone disease

Inclusion criteria

• {"criterion_text":"- Cancer with inoperable thoracic and/or lumbar vertebral metastases"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Life expectancy greater than 1 year"}
• {"criterion_text":"- WHO or PS ≤ 2"}
• {"criterion_text":"- Effective contraception for women of childbearing age"}
• {"criterion_text":"- Informing the patient and obtaining free, informed and written consent, signed by the patient and the investigator"}
• {"criterion_text":"- Patient affiliated to or benefiting from the social security system"}

Exclusion criteria

• {"criterion_text":"- Painful patient unable to maintain a supine position for 30 minutes despite analgesic treatment;"}
• {"criterion_text":"- Patient under guardianship or unable to give consent;"}
• {"criterion_text":"- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons."}
• {"criterion_text":"- Previous treatment with desonumab within the last 6 months or ongoing at inclusion."}
• {"criterion_text":"- Patients with severe untreated hypocalcaemia."}
• {"criterion_text":"- suppressed"}
• {"criterion_text":"- Signs of neurological compression"}
• {"criterion_text":"- Spinal cord compression or epidural involvement requiring surgery prior to radiotherapy;"}
• {"criterion_text":"- Clinically significant hypersensitivity to zoledronic acid or denosumab, other bisphosphonates or any excipient;"}
• {"criterion_text":"- A history of osteonecrosis of the jawbone or exposed bone or delayed healing after dental surgery;"}
• {"criterion_text":"- Previous bisphosphonate treatment within the last 24 months or ongoing at inclusion;"}
• {"criterion_text":"- Creatinine clearance < 30 ml/min;"}
• {"criterion_text":"- Pregnant or breast-feeding woman;"}

Primary endpoints

• {"endpoint_text":"- of life gained in good health. Calculating the ICER requires : - Identifying care consumption; - Measuring costs; - Estimating overall survival; - Calculating utilities using the EQ5D-5L questionnaire (appendix 11). The ROCR will be measured at 6 months and 24 months after the start of radiotherapy.","definition_or_measurement_approach":"Calculation of an incremental cost-effectiveness ratio / Differential Cost Outcome Ratio using identification of care consumption, measurement of costs, overall survival estimation and utilities from the EQ-5D-5L questionnaire. Measured at 6 months and 24 months after start of radiotherapy."}

Secondary endpoints

• {"endpoint_text":"- Cost-effectiveness analysis: calculation of a Differential Cost Outcome Ratio (DCOER) expressed as a cost per life-year gained measured at 6 months and 24 months from the start of radiotherapy;","definition_or_measurement_approach":"Calculation of DCOER expressed as cost per life-year gained; measured at 6 and 24 months from start of radiotherapy."}
• {"endpoint_text":"- Budget impact analysis: estimation of the target and reached populations, calculation of the additional costs and avoided costs generated by the diffusion of the innovation in the French healthcare system.","definition_or_measurement_approach":"Estimation of target and reached populations and calculation of additional and avoided costs to the French healthcare system."}
• {"endpoint_text":"- Survival without CVF (vertebral compression fractures) estimated at 6, 12 and 24 months.","definition_or_measurement_approach":"Vertebral compression fracture-free survival assessed at 6, 12 and 24 months."}
• {"endpoint_text":"- Survival without bone complications estimated at 6, 12 and 24 months","definition_or_measurement_approach":"Bone complication-free survival (fracture, cementoplasty, bone surgery and spinal cord compression) assessed at 6, 12 and 24 months."}
• {"endpoint_text":"- Acute and delayed toxicity: according to CTCAE 5 ;","definition_or_measurement_approach":"Toxicity graded and assessed according to CTCAE v5 criteria."}
• {"endpoint_text":"- Pain control: VAS and BPI (appendix 12) assessed at inclusion, 6, 12 and 24 months;","definition_or_measurement_approach":"Pain assessed using VAS and Brief Pain Inventory at baseline, 6, 12 and 24 months."}
• {"endpoint_text":"- Local control of irradiated tumour lesions: MRI and TAP and/or PET scan (quarterly monitoring or in the event of neurological signs) assessed at 6 and 12 months;","definition_or_measurement_approach":"Local control assessed by MRI and CT (TAP) and/or PET at 6 and 12 months; quarterly monitoring or earlier if neurological signs occur."}
• {"endpoint_text":"- Neoplastic Spinal Instability Score (NSSI) assessed at inclusion, 6 and 12 months","definition_or_measurement_approach":"Neoplastic Spinal Instability Score (SINS) evaluated at baseline, 6 and 12 months; score classification described in protocol (0–6 stable; 7–12 indeterminate; 13–18 instability)."}
• {"endpoint_text":"- Assessment of bone density: bone densitometry at inclusion, 6 and 12 months;","definition_or_measurement_approach":"Bone mineral density measured by densitometry at baseline, 6 and 12 months."}
• {"endpoint_text":"- Measurement of markers of immune response and bone remodelling;","definition_or_measurement_approach":"Biological collection and assays to measure immune response markers and bone remodelling markers as specified in protocol."}
• {"endpoint_text":"- Sensitivity and specificity of the algorithm for detecting the risk of fracture at 1 year.","definition_or_measurement_approach":"Performance (sensitivity and specificity) of a predictive algorithm for 1-year fracture risk, assessed against imaging/clinical outcomes at 1 year."}

France

Earliest CTIS Part Ii Submission Date

28-05-2024

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

451

Number Of Sites

11

Number Of Participants

202

Primary sponsor

Full Name

Institut De Cancerologie De L Ouest

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"INCA (AAP DOM)","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"DGOS Inca PRME 2017 (PRME17-0118)","duties_or_roles":"Source of monetary support","organisation_type":""}