Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
GCT is a potentially malignant tumour that presents with a locally destructive osteolytic
lesion. The high risk GCT are characterized by a high recurrence rate around the 40-45%.
Zoledronic acid is a potent inhibitor of osteolysis and is capable of inducing osteoclast
and stromal cell apoptosis, which makes it an attractive adjuvant treatment in 'high risk'
GCT in order to improve clinical outcomes and reduce the recurrence rate.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
J R Kroep, MD PhD
Leiden University Medical Center (LUMC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)