Clinical Trial: Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study
Brief 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 Summary: 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.
Sponsor: Leiden University Medical Center
Current Primary Outcome: Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care [ Time Frame: 4 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT [ Time Frame: 4 years ]
- Determine the relapse free survival [ Time Frame: 4 years ]
Original Secondary Outcome: Same as current
Information By: Leiden University Medical Center
Dates:
Date Received: April 28, 2009
Date Started: December 2008
Date Completion:
Last Updated: January 25, 2016
Last Verified: January 2016
