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

NCT05595603 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Phase 2

Started

2023-03

Last updated

2023-03-15

Condition(s) studied

Giant Cell Tumor of Bone

Investigational drug(s) / intervention(s)

4mg ZOL loaded gentamicin PMMAgentamicin PMMA

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.

Study 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 ).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
The Second Affiliated Hospital of Zhejiang University	Hangzhou	China	Recruiting

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Other trials for the same condition

Efficacy of ICG-based NIR Imaging in Intralesional Curettage of Giant Cell Tumors of Bone in Limbs: a Prospective, Single-center, Single-arm, Open Study Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05595603 on ClinicalTrials.gov ↗ ← All trials in China