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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
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
Study Summary
This trial is testing whether a bisphosphonate can prevent giant cell tumors from recurring after surgery.
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.Check my eligibility
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.See study design
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 belowSelect...
My cancer is in an arm or leg.
Select...
I have not taken bisphosphonates or denosumab before.
Select...
I have a non-cancerous tumor in my bone.
Select...
My lesion can be treated by removing it while keeping one solid piece of bone intact.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The endpoint for patient participation will be local recurrence
Secondary outcome measures
MSTS Score
Potential bisphosphonate complications related to systemic administration
Surgical site infection
+1 moreSide effects data
From 2020 Phase 4 trial • 61 Patients • NCT0308785190%
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
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
Find a Location
Who is running the clinical trial?
Orthopaedic Research and Education FoundationUNKNOWN
1 Previous Clinical Trials
36 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
978 Previous Clinical Trials
7,386,384 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,941 Previous Clinical Trials
13,200,548 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in an arm or leg.My bone cancer has come back.I have not taken bisphosphonates or denosumab before.My cancer is not located in my arms or legs.My lesion cannot be treated by direct injection due to its size or impact on bones or joints.I am not pregnant and do not plan to become pregnant during the trial. I do not have children participating in this trial.My lesion can be treated by removing it while keeping one solid piece of bone intact.I have been treated with bisphosphonates or denosumab before.I have a non-cancerous tumor in my bone.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: Bisphosphonate group
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what purpose is Zoledronic Acid most commonly prescribed?
"Zoledronic Acid is a medication that is used to treat solid tumors. Zoledronic Acid is also effective at treating other conditions like bone mineral density, chemotherapy, and osteoporosis."
Answered by AI
Does Zoledronic Acid have a history of being studied in other clinical trials?
"41 clinical trials involving Zoledronic Acid are currently underway, with 8 of those in Phase 3. Zoledronic Acid trials are being conducted in Douliu, Yunlin County and 697 other locations."
Answered by AI
Could you please explain the risks associated with taking Zoledronic Acid?
"Zoledronic Acid is thought to be safe according to our 3-point scale at Power, as it is a Phase 3 trial with evidence of efficacy and rounds of safety data."
Answered by AI
In how many different geographical areas is this trial taking place?
"This study is being conducted at 13 sites, which include Boston Children's Hospital in Winston-Salem, Massachusetts General Hospital in Montréal, and Wake Forest University in Baltimore, among others."
Answered by AI
Are investigators still enrolling new participants for this research study?
"That is correct, the clinicaltrials.gov website says that this study is open for recruitment. The listing was first put up on 2018-05-03 and updated as recently as 2022-10-19. They are hoping to have 120 people total across 13 different locations."
Answered by AI
How many individuals are participating in this research?
"In order for this trial to be completed, a total of 120 participants are required. These individuals must meet the specific inclusion criteria and can come from different locations, such as Boston Children's Hospital in Winston-Salem, North carolina or Massachusetts General Hospital in Montréal, Quebec."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Developed giant cell tumor after diet change it is none malignant as I am always in perfect health I want to be helpful to cure cancer once as for all to be usable to enable better medicine.
PatientReceived 2+ prior treatments
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