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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of vertebral metastases, which are cancerous growths that have spread to the bones of the spine. The study is investigating the effectiveness of adding two medications, Zoledronic Acid and Denosumab, to a type of precise radiation therapy called stereotactic radiotherapy. Zoledronic Acid is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. Denosumab, also known by code names such as AMG 162, is given as a solution for injection under the skin.

The purpose of the study is to evaluate how well these medications work when combined with stereotactic radiotherapy in treating vertebral metastases. Participants in the study will receive either Zoledronic Acid or Denosumab along with their radiation therapy. The study will last for up to 12 months, during which time the effects of the treatment will be monitored. This includes assessing the control of pain, the stability of the spine, and the prevention of bone complications. Participants will undergo regular check-ups, including imaging tests like MRI scans, to monitor the progress of their treatment.

The study aims to provide valuable information on the cost-effectiveness and overall benefits of adding these medications to standard radiation therapy for patients with vertebral metastases. By analyzing the outcomes, researchers hope to improve treatment strategies and enhance the quality of life for individuals affected by this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing informed consent. Eligibility includes being over 18 years old, having inoperable vertebral bone metastases, and meeting specific health criteria.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate health status. This includes a review of medical history and current health conditions.

  3. Step 3

    Treatment allocation

    Participants are randomly assigned to receive either zoledronic acid or denosumab in addition to stereotactic radiotherapy.

  4. Step 4

    Medication administration

    Denosumab is administered as a subcutaneous injection using XGEVA 120 mg solution in a pre-filled syringe.

    Zoledronic acid is administered intravenously using Zometa 4 mg/100 ml solution for infusion.

  5. Step 5

    Radiotherapy

    Stereotactic radiotherapy is provided as part of the treatment for vertebral metastases.

  6. Step 6

    Follow-up assessments

    Follow-up assessments occur at 6, 12, and 24 months. These include evaluations of pain control, bone density, and tumour response using MRI and other scans.

    Additional assessments include monitoring for vertebral compression fractures and bone complications.

  7. Step 7

    End of study

    The study is estimated to conclude by June 2027. Final assessments will be conducted to evaluate the overall effectiveness and safety of the treatment.

Who can join the trial?

7 criteria

  • Must have cancer with **inoperable** thoracic and/or lumbar **vertebral metastases**. This means the cancer has spread to the spine and cannot be removed with surgery.
  • Must be **18 years or older**.
  • Must have a **life expectancy** of more than 1 year, meaning doctors expect the person to live longer than a year.
  • Must have a **WHO or PS ≤ 2**. This refers to a scale that measures how well a person can perform daily activities. A score of 2 or less means the person can do most activities but may need some help.
  • Women who can have children must use **effective contraception** to prevent pregnancy during the study.
  • Must be informed about the study and provide **written consent**. This means the person agrees to participate after understanding the study details.
  • Must be **affiliated with or benefiting from the social security system**, meaning they have access to social health benefits.

Who cannot join the trial?

4 criteria

  • Patients who are under 18 years old.
  • Patients who have operable vertebral bone metastases. This means if the bone cancer in the spine can be treated with surgery, they cannot participate.
  • Patients who do not require treatment with **stereotactic radiotherapy**. This is a type of radiation therapy that precisely targets tumors.
  • Patients who are part of a vulnerable population. This generally includes groups like pregnant women, children, or those unable to give consent.
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Investigated drugs

  • Zoledronic Acid

    is a medication used to treat bone problems that occur with certain types of cancer. In this trial, it is being evaluated for its effectiveness in combination with stereotactic radiotherapy to treat vertebral metastases, which are cancerous growths in the spine.

  • Denosumab

    is a medication that helps prevent bone complications in patients with cancer. It is being tested in this study to see how well it works when added to stereotactic radiotherapy for treating vertebral metastases.

What is already known about the treatment

  • Zoledronic Acid

    Zoledronic acid is administered intravenously, typically as an infusion. It is currently used in medicine to treat bone complications associated with cancer, such as vertebral bone metastases. The main therapeutic indication for zoledronic acid is to prevent skeletal-related events in patients with bone metastases. At the molecular level, it works by inhibiting osteoclast-mediated bone resorption, which helps to strengthen bones and reduce fractures. Zoledronic acid is classified as a bisphosphonate, a type of medication that helps to protect bone density.

  • Denosumab

    Denosumab is administered via subcutaneous injection. It is widely recognized in medical literature for its role in managing bone loss conditions, particularly in cancer patients with bone metastases. The primary therapeutic indication for denosumab is to prevent bone complications in patients with bone metastases. Its mechanism of action involves binding to and inhibiting a protein called RANKL, which is essential for the formation and function of osteoclasts, thereby reducing bone resorption. Denosumab is classified as a monoclonal antibody, a type of medication that targets specific proteins in the body.

Investigated diseases

Vertebral Bone Metastases – Vertebral bone metastases occur when cancer cells spread from their original site to the bones of the spine. This condition is often associated with cancers such as breast, prostate, and lung cancer. As the cancer cells invade the vertebrae, they can weaken the bone structure, leading to pain and an increased risk of fractures. Over time, the affected vertebrae may become unstable, potentially compressing the spinal cord or nerves, which can result in neurological symptoms. The progression of vertebral bone metastases can vary depending on the type of primary cancer and the extent of bone involvement. Management focuses on controlling symptoms and maintaining quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513248-27-00Protocol codeZOSTER ICO-N-2018-14Estimated enrolment202 patientsSponsorInstitut De Cancerologie De L Ouest

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