Clinical trial NCT05595603: Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Giant Cell Tumor of Bone
Keywords: Zoledronic Acid, intralesional curettage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 153
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ).

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.

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

Primary outcomes:
measure: time to first local recurrence
timeFrame: All patients will be followed for this endpoint until 18 months postoperatively
Secondary outcomes:
measure: MSTS score
timeFrame: Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up
measure: TESS score
timeFrame: Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively
measure: postoperative complication
timeFrame: Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up
measure: Potential ZOL-related complications
timeFrame: Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
Study officials:
References: