Clinical Trials Logo
  1. Home
  2. Giant Cell Tumor of Bone
  3. NCT00889590

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

Giant Cell Tumor of Bone Clinical Trial

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

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00889590
Study type Interventional
Source Leiden University Medical Center
Contact
Status Terminated
Phase Phase 2
Start date December 2008
Completion date July 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Active, not recruiting NCT04255576 - Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of Bone Phase 1/Phase 2
Completed NCT03301857 - Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004 Phase 4
Completed NCT05402865 - A Real-world Study on Patients of Unresectable Giant Cell Tumor of Bone
Recruiting NCT03295981 - Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone Phase 3
Completed NCT00464620 - Trial of Dasatinib in Advanced Sarcomas Phase 2
Recruiting NCT03259152 - Characteristics and Mechanism of Denosumab-treated Giant Cell Tumor of Bone Phase 3
Recruiting NCT05595603 - Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage Phase 2
Not yet recruiting NCT03358212 - Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China N/A
Completed NCT04002817 - Giant Cell Tumor of the Bone in Young Patients
Completed NCT00396279 - Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone Phase 2
Recruiting NCT04586660 - Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone Phase 4
Active, not recruiting NCT03449108 - LN-145 or LN-145-S1 in Treating Patients With Relapsed or Refractory Ovarian Cancer, Triple Negative Breast Cancer (TNBC), Anaplastic Thyroid Cancer, Osteosarcoma, or Other Bone and Soft Tissue Sarcomas Phase 2
Not yet recruiting NCT05813665 - A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone Phase 3
Completed NCT02996734 - Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment N/A