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New treatment option for Giant Cell Tumor of Bone
Official title Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage
ClinicalTrials.gov ID: NCT05595603
What this study is testing
- What it's testing
- 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 ).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.