Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate whether zoledronic acid-loaded bone cement (4mg ZOL+ gentamicin PMMA ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. The hypothesis is that patients with local administration of zoledronic acid to the bone cement has lower relapse rate compared those with traditional bone cement(gentamicin PMMA ).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of the Effect of Zoledronate on Local Recurrence After Surgical Treatment of Giant Cell Tumors of Bone Zométa

NCT01564121

Giant Cell Tumors of Bone

TERMINATED PHASE1/PHASE2

Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone

NCT03295981

Giant Cell Tumor of Bone

RECRUITING PHASE3

S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases

NCT00874211

Breast Cancer Lung Cancer Metastatic Cancer +4 more

COMPLETED

Effect of Zoledronic Acid Treatment on Bone-related Events in Breast Cancer Patients With Bone Metastases: a Prospective, Multicenter, Real-world Study

NCT05480189

Histologically Confirmed Breast Cancer ,Diagnosis of Bone Metastasis

NOT_YET_RECRUITING

Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)

NCT00889590

Giant Cell Tumor of Bone Osteoclastoma

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of the clinical study is to investigate whether the local delivery of zoledronic acid (4mg ZOL-loaded gentamicin PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will also evaluate whether patients with zoledronic acid as a surgical adjuvant improves secondary outcomes, including function (MSTS and TESS), surgery related complications (henderson's failure mode) and ZOL-related complications.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Giant Cell Tumor of Bone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Zoledronic Acid loaded bone cement

4mg zoledronic acid-loaded gentamicin bone cement (PMMA)

Group Type EXPERIMENTAL

4mg ZOL loaded gentamicin PMMA

Intervention Type PROCEDURE

During surgery, 4mg ZOL will be mixed with gentamicin (1000mg) PMMA cement (40g) by surgeon under sterile conditions to prepare ZOL loaded bone cement, and then it will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.

conventional gentamicin bone cement

gentamicin bone cement (PMMA)

Group Type ACTIVE_COMPARATOR

gentamicin PMMA

Intervention Type PROCEDURE

During surgery, gentamicin (1000mg) PMMA (40g) was prepared by surgeon under sterile conditions and will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

4mg ZOL loaded gentamicin PMMA

During surgery, 4mg ZOL will be mixed with gentamicin (1000mg) PMMA cement (40g) by surgeon under sterile conditions to prepare ZOL loaded bone cement, and then it will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.

Intervention Type PROCEDURE

gentamicin PMMA

During surgery, gentamicin (1000mg) PMMA (40g) was prepared by surgeon under sterile conditions and will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with primary resectable GCT of bone
* lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
* no previous systemic bisphosphonate or denosumab therapy
* with expected longer than 18 months of survival time
* sign the informed consent form

Exclusion Criteria

* patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature.
* conduct unexpected surgery at other center
* the primary goal for surgery is revision
* patient conduct en-bloc/wide resection instead of curettage surgery
* patient can not conduct self-assessment during follow up
* difficulty in complete postoperative follow-up
* previous use of bisphosphonate/ZOL or denosumab drug
* patients have participated in similar research projects
* refused to sign informed consent

Eligible Sex

ALL

Accepts Healthy Volunteers

No