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

Giant Cell Tumor of Bone Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595603
• Other study ID #: 2022_LM1020
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Meng Liu, MD
• Phone: 13515711791
• Email: liumeng80[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 153
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Giant Cell Tumor of Bone
• Giant Cell Tumors

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first local recurrence	Time to first local recurrence will be reported during postoperative 18-month follow up period	All patients will be followed for this endpoint until 18 months postoperatively
Secondary	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	Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up
Secondary	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	Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively
Secondary	postoperative complication	Including wound healing problem, mechanical failure, infection and any tumor progression issues	Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up
Secondary	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	Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.