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

Primary Purpose

Giant Cell Tumor of Bone

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

4mg ZOL loaded gentamicin PMMA

gentamicin PMMA

About this trial

This is an interventional treatment trial for Giant Cell Tumor of Bone focused on measuring Zoledronic Acid, intralesional curettage

Eligibility Criteria

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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

Sites / Locations

The Second Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zoledronic Acid loaded bone cement

conventional gentamicin bone cement

Arm Description

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

gentamicin bone cement (PMMA)

Outcomes

Primary Outcome Measures

time to first local recurrence

Time to first local recurrence will be reported during postoperative 18-month follow up period

Secondary Outcome Measures

MSTS score

The Musculoskeletal Tumor Society (MSTS) scoring system is a disease-specific instrument to determine the physical and mental health for patients underwent limb-salvage surgery after tumor resection and is a validated and well-accepted functional scoring system used in orthopaedic oncology research

TESS score

The Toronto Extremity Salvage Score (TESS) is a physical disability measure developed specifically for patients undergoing surgery for extremity tumours and has been shown to have superior measurement properties compared with other commonly used sc

postoperative complication

Including wound healing problem, mechanical failure, infection and any tumor progression issues

Potential ZOL-related complications

Patients will be followed for atypical bone fractures and avascular necrosis (AVN) of jaw, one of the most severe complication of ZOL

Full Information

NCT ID

NCT05595603

First Posted

October 23, 2022

Last Updated

March 13, 2023

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05595603

Brief Title

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

Official Title

Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage: a Prospective, Multicenter, Single Blinded, Randomized Control Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 2023 (Anticipated)

Primary Completion Date

June 1, 2026 (Anticipated)

Study Completion Date

December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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 ).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Giant Cell Tumor of Bone

Keywords

Zoledronic Acid, intralesional curettage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

153 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Zoledronic Acid loaded bone cement

Arm Type

Experimental

Arm Description

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

Arm Title

conventional gentamicin bone cement

Arm Type

Active Comparator

Arm Description

gentamicin bone cement (PMMA)

Intervention Type

Procedure

Intervention Name(s)

4mg ZOL loaded gentamicin PMMA

Intervention Description

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

Intervention Name(s)

gentamicin PMMA

Intervention Description

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.

Primary Outcome Measure Information:

Title

time to first local recurrence

Description

Time to first local recurrence will be reported during postoperative 18-month follow up period

Time Frame

All patients will be followed for this endpoint until 18 months postoperatively

Secondary Outcome Measure Information:

Title

MSTS score

Description

Time Frame

Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up

Title

TESS score

Description

Time Frame

Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively

Title

postoperative complication

Description

Including wound healing problem, mechanical failure, infection and any tumor progression issues

Time Frame

Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up

Title

Potential ZOL-related complications

Description

Patients will be followed for atypical bone fractures and avascular necrosis (AVN) of jaw, one of the most severe complication of ZOL

Time Frame

Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meng Liu, MD

Phone

13515711791

liumeng80@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Keyi Wang, MS

Phone

17398046579

wky82630965@gmail.com

Facility Information:

Facility Name

The Second Affiliated Hospital of Zhejiang University

City

Hangzhou

ZIP/Postal Code

311200

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meng Liu

Phone

13515711791

liumeng80@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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