NCT05595603

Brief 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 ).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for phase_2

Timeline
7mo left

Started Mar 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

October 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 15, 2023

Status Verified

October 1, 2022

Enrollment Period

3.3 years

First QC Date

October 23, 2022

Last Update Submit

March 13, 2023

Conditions

Giant Cell Tumor of Bone

Keywords

Zoledronic Acid, intralesional curettage

Outcome Measures

Primary Outcomes (1)

  • time to first local recurrence

    Time to first local recurrence will be reported during postoperative 18-month follow up period

    All patients will be followed for this endpoint until 18 months postoperatively

Secondary Outcomes (4)

  • MSTS score

    Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up

  • TESS score

    Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively

  • postoperative complication

    Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up

  • Potential ZOL-related complications

    Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.

Study Arms (2)

Zoledronic Acid loaded bone cement

EXPERIMENTAL

4mg zoledronic acid-loaded gentamicin bone cement (PMMA)

Procedure: 4mg ZOL loaded gentamicin PMMA

conventional gentamicin bone cement

ACTIVE COMPARATOR

gentamicin bone cement (PMMA)

Procedure: gentamicin PMMA

Interventions

4mg ZOL loaded gentamicin PMMAPROCEDURE

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.

Zoledronic Acid loaded bone cement
gentamicin PMMAPROCEDURE

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.

conventional gentamicin bone cement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, 311200, China

RECRUITING

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

gentamicin-polymethylmethacrylate bead

Condition Hierarchy (Ancestors)

Giant Cell TumorsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone Tissue

Central Study Contacts

Meng Liu, MD

CONTACT

13515711791liumeng80@163.com

Keyi Wang, MS

CONTACT

17398046579wky82630965@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2022

First Posted

October 27, 2022

Study Start

March 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 15, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)