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Study on Zoledronic Acid for Treating Osteosarcoma in Children, Adolescents, and Adults

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 a type of bone cancer called osteosarcoma, which can occur in children, adolescents, and adults. The trial is investigating the use of a medication called zoledronic acid, which is given as a solution through a vein, known as an infusion. The purpose of the study is to compare the outcomes of patients with osteosarcoma who receive standard treatment, which includes chemotherapy and surgery, with those who receive the same treatment plus zoledronic acid.

Participants in the study will be randomly assigned to one of two groups. One group will receive the standard treatment, while the other group will receive the standard treatment along with zoledronic acid. The study will monitor the progression of the disease and assess how long patients remain free from cancer progression. Additionally, the study will look at overall survival rates, the body's response to treatment, and the impact on bone health and quality of life.

The trial will also include biological studies to better understand the effects of the treatment. The study is expected to continue until the end of 2025, and it aims to provide valuable information on the potential benefits of adding zoledronic acid to the treatment plan for patients with osteosarcoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have a confirmed diagnosis of high-grade osteosarcoma and meet specific criteria, including age between 5 and 50 years, no prior treatment for this or another cancer, and the ability to follow long-term care.

    The patient must provide informed consent, with parental authorization required for minors. Effective contraception is necessary for women of childbearing age.

  2. Step 2

    Initial treatment phase

    The treatment involves a combination of chemotherapy and surgery. The patient may receive zoledronic acid as part of the treatment, which is administered as a solution for infusion through an intravenous route.

    The specific product used is Zometa 4 mg/100 ml solution for infusion. The frequency and duration of administration will be determined by the healthcare provider based on the treatment protocol.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, the patient's progression-free survival will be monitored. This involves regular assessments to determine the effectiveness of the treatment in preventing the progression of the disease.

    The primary endpoint is event-free survival at 3 years, with secondary endpoints including overall survival, histological response, short-term and long-term toxicity, bone metabolism, and quality of life.

  4. Step 4

    Completion of the trial

    The estimated end date for the trial is December 21, 2025. Upon completion, the data collected will be analyzed to assess the outcomes of the treatment protocol.

    The results will contribute to understanding the effectiveness of the treatment for osteosarcoma in children, adolescents, and adults.

Who can join the trial?

9 criteria

  • The patient must have a confirmed diagnosis of **high-grade osteosarcoma**, which is a type of bone cancer.
  • The patient must be between **5 and 50 years old**.
  • The patient must not have any medical reasons that would prevent them from receiving the planned treatments.
  • The patient must not have received chemotherapy or radiation therapy for this tumor or any other cancer before.
  • The patient must have signed an **informed consent form**, which is a document that explains the study and confirms the patient's agreement to participate. If the patient is a minor, their parent or guardian must give permission. If one parent cannot give permission in time, the other parent can do so alone.
  • The patient must be able to have **long-term follow-up**, meaning they can be monitored over a long period.
  • The patient must be registered with the study center as soon as they give consent, and no later than the third day after starting the first course of chemotherapy.
  • Women who can have children must use **effective contraception** to prevent pregnancy during the study.
  • The patient must be a member of a **social security scheme**, which is a system that provides health and financial support.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer than high grade osteosarcoma cannot participate. Osteosarcoma is a type of bone cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups.
  • Patients who are not able to undergo the required treatments, such as chemotherapy or surgery, cannot participate. Chemotherapy is a treatment using special drugs to kill cancer cells.
  • Patients who have medical conditions that make it unsafe for them to receive the study treatments cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the treatments may affect the baby.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
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Investigated drugs

Zoledronic Acid is a medication used in this trial to see if it can help improve the outcomes for patients with osteosarcoma. It is being tested to determine if it can help prevent the cancer from progressing when used alongside standard chemotherapy and surgery.

What is already known about the treatment

Zoledronic Acid – This medication is administered intravenously, meaning it is given through a vein. It is currently being studied in clinical trials for its potential use in treating high-grade osteosarcoma, a type of bone cancer. Zoledronic acid is primarily used to prevent bone complications in cancer patients, but in this trial, it is being evaluated for its ability to improve progression-free survival when combined with chemotherapy and surgery. At the molecular level, zoledronic acid works by inhibiting an enzyme involved in bone resorption, which helps to strengthen bones and prevent fractures. It is classified as a bisphosphonate, a type of drug that affects bone metabolism.

Investigated diseases

High-grade osteosarcoma – High-grade osteosarcoma is a type of bone cancer that typically occurs in the long bones, such as those in the arms and legs. It is characterized by the rapid growth of malignant cells that form a tumor in the bone. This disease often affects teenagers and young adults, although it can occur at any age. The cancerous cells in high-grade osteosarcoma are aggressive and can spread to other parts of the body, particularly the lungs. Symptoms may include localized pain, swelling, and decreased joint movement. As the disease progresses, the affected bone may become weakened, leading to fractures.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514756-32-00Protocol codeUC-0150/ 0603Estimated enrolment653 patientsSponsorUnicancer

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