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.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Meng Liu, MD
liumeng80@163.com
13515711791
Backup
Keyi Wang, MS
wky82630965@gmail.com
17398046579
Time Frame
Start Date: 2023-03
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 153
Treatments
Experimental: Zoledronic Acid loaded bone cement
4mg zoledronic acid-loaded gentamicin bone cement (PMMA)
Active_comparator: conventional gentamicin bone cement
gentamicin bone cement (PMMA)
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University