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Zoledronic Acid for Giant Cell Tumor of Bone

Phase 3
Recruiting
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lesion located in an extremity
No previous systemic bisphosphonate or denosumab therapy
Must not have
Recurrent GCT of bone
Previous systemic bisphosphonate or denosumab therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-ups will consist of clinical visits. the clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial is testing a special bone cement with a drug to see if it can help prevent giant cell tumors of bone from coming back after surgery. The cement is applied during surgery to kill any remaining tumor cells and make the bone stronger. The drug is known for its ability to inhibit bone resorption and has shown antitumor activity in various cancers.

Who is the study for?
This trial is for adults with a primary benign giant cell tumor of bone located in an arm or leg, who haven't had bisphosphonate or denosumab therapy before. The tumor must be treatable by removing it and reconstructing the area. It's not for children, pregnant individuals, those with recurring tumors, extensive tumors unsuitable for this treatment approach, or non-extremity tumors.
What is being tested?
The study tests if applying Zoledronic Acid directly to the site where a giant cell bone tumor was removed can prevent it from returning. This local treatment is compared to just surgically removing the tumor without any additional medication.
What are the potential side effects?
While specific side effects are not listed here, bisphosphonates like Zoledronic Acid may generally cause flu-like symptoms, pain at the injection site, nausea, and occasionally affect kidney function or cause jawbone problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in an arm or leg.
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I have not taken bisphosphonates or denosumab before.
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I have a non-cancerous tumor in my bone.
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My lesion can be treated by removing it while keeping one solid piece of bone intact.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My bone cancer has come back.
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I have been treated with bisphosphonates or denosumab before.
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My lesion cannot be treated by direct injection due to its size or impact on bones or joints.
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I am not pregnant and do not plan to become pregnant during the trial. I do not have children participating in this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-ups will consist of clinical visits. the clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-ups will consist of clinical visits. the clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The endpoint for patient participation will be local recurrence
Secondary study objectives
MSTS Score
Potential bisphosphonate complications related to systemic administration
Surgical site infection
+1 more

Side effects data

From 2020 Phase 4 trial • 61 Patients • NCT03087851
90%
Infection (unspecified) + Musculoskeletal symptoms
40%
Flu-like symptoms after ZOL treatment
10%
Fracture
5%
Cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
9-months Group
Observation Group
6-month Group

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bisphosphonate groupExperimental Treatment1 Intervention
In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.
Group II: Control groupActive Control1 Intervention
The surgical procedure for all patients will include extensive curettage of the lesion to remove macroscopic tumor, high-speed burring of the residual cavity, adjuvant treatment to the residual cavity, followed by packing of the cavity with either polymethylmethacrylate (PMMA) bone cement (Simplex P; Stryker, Mahwah, New Jersey) alone or bone cement with subchondral allograft bone graft. The choice of cavity reconstruction will be at the discretion of the treating surgeon. Traditional local adjuvants (argon beam coagulation, phenol, ethanol, or cryotherapy) will be used depending on surgeon preference. In addition to the above standard treatment, the patients will be randomized into one of two study arms. In Arm 1, the control group, no additional local therapy will be utilized.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zoledronic acid
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Bisphosphonates, commonly used in the treatment of Giant Cell Tumor (GCT), work by inhibiting osteoclast-mediated bone resorption. This mechanism is crucial for GCT patients because these tumors are characterized by aggressive bone destruction due to the activity of osteoclast-like giant cells. By inhibiting these cells, bisphosphonates can help reduce bone resorption, potentially decreasing the recurrence rate of the tumor and preserving bone integrity. This can lead to better surgical outcomes and lower the risk of tumor recurrence, which is vital for the long-term management of GCT.

Find a Location

Who is running the clinical trial?

Orthopaedic Research and Education FoundationUNKNOWN
1 Previous Clinical Trials
36 Total Patients Enrolled
University of WashingtonOTHER
1,824 Previous Clinical Trials
1,913,230 Total Patients Enrolled
University of CaliforniaOTHER
45 Previous Clinical Trials
306,926 Total Patients Enrolled

Media Library

Zoledronic Acid Clinical Trial Eligibility Overview. Trial Name: NCT03295981 — Phase 3
Giant Cell Tumor Research Study Groups: Control group, Bisphosphonate group
Giant Cell Tumor Clinical Trial 2023: Zoledronic Acid Highlights & Side Effects. Trial Name: NCT03295981 — Phase 3
Zoledronic Acid 2023 Treatment Timeline for Medical Study. Trial Name: NCT03295981 — Phase 3
~16 spots leftby Jan 2026