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Multicentre, randomized, controlled, open-label, multi-centre medicoeconomic study evaluating the efficacy of adding zoledronic acid or denosumab to Stereotaxic radiotherapy in the treatment of vertebral metastases (ZOSTER)
EU CTIS ID: 2024-513248-27-00
What this study is testing
to evaluate, on the basis of a cost-utility analysis and a randomised phase 3 study, the efficacy of adding zoledronic acid or denosumab to stereotactic radiotherapy in the treatment of vertebral metastases
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cancer with inoperable thoracic and/or lumbar vertebral metastases
- Age ≥ 18 years
- Life expectancy greater than 1 year
- WHO or PS ≤ 2
- Effective contraception for women of childbearing age
- Informing the patient and obtaining free, informed and written consent, signed by the patient and the investigator
You likely can't join if
- Painful patient unable to maintain a supine position for 30 minutes despite analgesic treatment;
- Patient under guardianship or unable to give consent;
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
- Previous treatment with desonumab within the last 6 months or ongoing at inclusion.
- Patients with severe untreated hypocalcaemia.
- suppressed
See the full eligibility criteria
- Cancer with inoperable thoracic and/or lumbar vertebral metastases
- Age ≥ 18 years
- Life expectancy greater than 1 year
- WHO or PS ≤ 2
- Effective contraception for women of childbearing age
- Informing the patient and obtaining free, informed and written consent, signed by the patient and the investigator
- Patient affiliated to or benefiting from the social security system
- Painful patient unable to maintain a supine position for 30 minutes despite analgesic treatment;
- Patient under guardianship or unable to give consent;
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
- Previous treatment with desonumab within the last 6 months or ongoing at inclusion.
- Patients with severe untreated hypocalcaemia.
- suppressed
- Signs of neurological compression
- Spinal cord compression or epidural involvement requiring surgery prior to radiotherapy;
- Clinically significant hypersensitivity to zoledronic acid or denosumab, other bisphosphonates or any excipient;
- A history of osteonecrosis of the jawbone or exposed bone or delayed healing after dental surgery;
- Previous bisphosphonate treatment within the last 24 months or ongoing at inclusion;
- Creatinine clearance < 30 ml/min;
- Pregnant or breast-feeding woman;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.