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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 4mg ZOL loaded gentamicin PMMA
  • gentamicin PMMA

Treatment groups

153 Participants
are divided into 2 treatment groups