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

Phase 2

Recruiting

• Conditions: Giant Cell Tumor of Bone
• Interventions: Procedure: 4mg ZOL loaded gentamicin PMMA; Procedure: gentamicin PMMA

• Registration Number: NCT05595603
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Study Start: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic Acid loaded bone cement	4mg ZOL loaded gentamicin PMMA	4mg zoledronic acid-loaded gentamicin bone cement (PMMA)
conventional gentamicin bone cement	gentamicin PMMA	gentamicin bone cement (PMMA)

Primary Outcome Measures

Name	Time	Method
time to first local recurrence	All patients will be followed for this endpoint until 18 months postoperatively	Time to first local recurrence will be reported during postoperative 18-month follow up period

Secondary Outcome Measures

Name	Time	Method
Potential ZOL-related complications	Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.	Patients will be followed for atypical bone fractures and avascular necrosis (AVN) of jaw, one of the most severe complication of ZOL
MSTS score	Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up	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
postoperative complication	Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up	Including wound healing problem, mechanical failure, infection and any tumor progression issues
TESS score	Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively	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

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, China