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

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ClinicalTrials.gov Identifier: NCT00889590
Recruitment Status : Terminated (low recruitment with registration denosumab)
First Posted : April 29, 2009
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
J.R. Kroep, Leiden University Medical Center

April 28, 2009
April 29, 2009
January 26, 2016
December 2008
May 2015   (Final data collection date for primary outcome measure)
Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care [ Time Frame: 4 years ]
Same as current
Complete list of historical versions of study NCT00889590 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Giant Cell Tumor of Bone
  • Osteoclastoma
Drug: Zoledronic acid
4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery
Other Name: Zometa
  • Experimental: Zoledronic acid
    Adjuvant zoledronic acid
    Intervention: Drug: Zoledronic acid
  • No Intervention: Control
    Standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
90
July 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed written informed consent
  • Male or female > 18 years of age
  • Histologically proven GCT treated with surgery
  • High risk GCT defined as minimal one or more of the following:

    • Recurrent GCT
    • GCT located in the pelvis, sacrum, spine, distal ulna or growth in soft tissue
    • GCT grade III
    • Pathological fracture in GCT
    • Absence of local adjuvant therapy (cryosurgery or phenol instillation)
  • Neutrophils > 1.5x109/L, platelets > 100x109/L, and Hb > 6 mmol/l
  • Bilirubin level < 1.5 x ULN
  • ASAT and ALAT < 2.5 x ULN
  • Adequate renal function as defined by: serum creatinine clearance > 60 cc/min
  • Expected adequacy of follow-up

Exclusion Criteria:

  • Unresectable or metastatic GCT and grade IV GCT
  • Prior bisphosphonate usage, except preoperative treatment with zoledronic acid up to 3 months before surgery
  • Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  • Known hypersensitivity reaction to any of the components of the treatment
  • Pregnancy or lactating
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
 
 
NCT00889590
P08.185
No
Not Provided
Not Provided
J.R. Kroep, Leiden University Medical Center
Leiden University Medical Center
Not Provided
Principal Investigator: J R Kroep, MD PhD Leiden University Medical Center (LUMC)
Study Director: P D Dijkstra, MD PhD LUMC
Study Director: A H Taminiau, MD PhD LUMC
Study Director: P C Hogendoorn, MD PhD LUMC
Study Director: H Gelderblom, MD PhD LUMC
Study Director: N A Hamdy, MD PhD LUMC
Study Director: S E Papapoulos, MD PhD LUMC
Leiden University Medical Center
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP