Cancer pain Trials in Disease

Study on Adding Zoledronic Acid or Denosumab to Radiotherapy for Adults with Inoperable Vertebral Bone Metastases

This clinical trial is being conducted in France and focuses on improving treatment for patients whose cancer has spread to the bones of the spine, causing pain and potential complications. The study investigates whether adding specific bone-protecting medications to a precise form of radiation therapy can provide better results for patients.

Main focus and goal: The trial aims to evaluate how well two different medications work when combined with stereotactic radiotherapy, a type of precise radiation treatment that targets tumors in the spine. Researchers want to understand if adding these medications can better control pain, maintain spine stability, and prevent bone complications over a period of up to 24 months. The study will also assess the cost-effectiveness of these treatment combinations and monitor outcomes through regular check-ups, including MRI scans and other imaging tests.

Investigational drugs: The trial is testing two medications:

• Zoledronic Acid is given as an infusion directly into the bloodstream through a vein. This medication belongs to a group called bisphosphonates and works by slowing down the breakdown of bone, which helps strengthen bones and reduce the risk of fractures.
• Denosumab is given as an injection under the skin. It is a monoclonal antibody that works by blocking a specific protein involved in bone breakdown, thereby protecting bone density and reducing complications.

Who can participate: This study is looking for adults aged 18 years or older who have cancer that has spread to the thoracic or lumbar spine and cannot be treated with surgery. Participants must have a life expectancy of more than one year and be able to perform most daily activities, though they may need some assistance. Women who can become pregnant must use effective contraception during the study. All participants must understand the study details and provide written consent, and they must have access to social health benefits.

Who cannot participate: The trial excludes patients under 18 years old and those whose vertebral bone cancer can be treated with surgery. Patients who do not need stereotactic radiotherapy or who belong to vulnerable populations, such as those unable to give informed consent, are also excluded from the study.

Summary

Currently, there is one ongoing clinical trial available for patients experiencing pain related to cancer that has spread to the spine. This trial is taking place in France and focuses on combining bone-protecting medications with precise radiation therapy to improve pain control and prevent bone complications. The study involves two well-known medications, Zoledronic Acid and Denosumab, both of which are designed to protect bone health in cancer patients. This research may provide valuable insights into more effective treatment strategies for patients with vertebral bone metastases who are not candidates for surgery.