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

RecruitingPhase 2Ages any - anyAllSecond Affiliated Hospital, Zhejiang University, …
NCT05595603 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ).

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📋 Eligibility rules (as published)
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
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What it tests

  • 4mg ZOL loaded gentamicin PMMA
  • gentamicin PMMA
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Where

1 site
The Second Affiliated Hospital of Zhejiang University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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