Ignite Creation Date:
2024-05-05 @ 9:25 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00889590
Status:
TERMINATED
Last Update Posted:
2016-01-26
First Post:
2009-04-28
Brief Title:
Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone GCT
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone GCT - A Randomized Phase II Study
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low recruitment with registration denosumab
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HR-GCT
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None