NCT05595603 Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage
| NCT ID | NCT05595603 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Giant Cell Tumor of Bone |
| Study Type | INTERVENTIONAL |
| Enrollment | 153 participants |
| Start Date | 2023-03 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 153 participants in total. It began in 2023-03 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 ).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05595603 clinical trial?
This trial is open to participants of all sexes, studying Giant Cell Tumor of Bone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05595603 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05595603 currently recruiting?
Yes, NCT05595603 is actively recruiting participants. Contact the research team at liumeng80@163.com for enrollment information.
Where is the NCT05595603 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05595603 clinical trial?
NCT05595603 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 153 participants.