Actively Recruiting

Phase 2
All Genders
NCT05595603

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2023-03-15

153

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 ).

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with primary resectable giant cell tumor of bone
  • Lesion suitable for intralesional curettage with at least one intact bone column after tumor removal
  • No previous treatment with systemic bisphosphonates or denosumab
  • Expected survival longer than 18 months
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Patients with recurrent or extensive giant cell tumor unsuitable for curettage surgery
  • Unexpected surgery at another center
  • Surgery planned as revision rather than primary treatment
  • Patients undergoing en-bloc or wide resection instead of curettage
  • Inability to complete self-assessment during follow-up
  • Difficulty completing full postoperative follow-up
  • Previous use of bisphosphonate, zoledronic acid, or denosumab
  • Participation in similar research projects
  • Refusal to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Zhejiang University

Hangzhou, China, 311200

Actively Recruiting

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Research Team

M

Meng Liu, MD

CONTACT

K

Keyi Wang, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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