NCT00889590

Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)

Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomised phase II trial in patients with high risk GCT. Primary objective: * Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of 'high risk' GCT as compared to standard care Secondary objectives: * Determine the relapse free survival * Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT

Detailed description

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.

Conditions

• Giant Cell Tumor of Bone
• Osteoclastoma

Interventions

Type	Name	Description
DRUG	Zoledronic acid	4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery

Timeline

• Start date: 2008-12-01
• Primary completion: 2015-05-01
• Completion: 2015-07-01
• First posted: 2009-04-29
• Last updated: 2016-01-26

Locations

4 sites across 2 countries: Belgium, Netherlands