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Recruiting NCT05595603

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

Phase II Interventional Giant Cell Tumor of Bone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 4mg ZOL loaded gentamicin PMMA, gentamicin PMMA.
Who it may be relevant to
Registry conditions: Giant Cell Tumor of Bone. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

Overview

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 ).

Detailed description

The purpose of the clinical study is to investigate whether the local delivery of zoledronic acid (4mg ZOL-loaded gentamicin PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will also evaluate whether patients with zoledronic acid as a surgical adjuvant improves secondary outcomes, including function (MSTS and TESS), surgery related complications (henderson's failure mode) and ZOL-related complications.

Interventions

  • Procedure 4mg ZOL loaded gentamicin PMMA
    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.
  • Procedure gentamicin PMMA
    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.

Primary outcome measures

  • time to first local recurrence [Time frame: All patients will be followed for this endpoint until 18 months postoperatively]
Secondary outcome measures (4)
  • MSTS score [Time frame: Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up]
  • TESS score [Time frame: Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively]
  • postoperative complication [Time frame: 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 [Time frame: Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Zhejiang University — Hangzhou

Identifiers

NCT: NCT05595603 · 2022_LM1020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗