Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low recruitment with registration denosumab
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Cell Tumor of Bone | Giant Cell Tumor of Bone | ONTOLOGY_EXACT | 0.98 |
| Osteoclastoma | Giant Cell Tumor of Bone | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zoledronic acid
- description
- Adjuvant zoledronic acid
- interventionNames
- Drug: Zoledronic acid
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard care
Primary outcomes (1)
- measure
- Determine if adjuvant zoledronic acid improves the 2 year recurrence rate of 'high risk' GCT as compared to standard care
- timeFrame
- 4 years
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLipplaa A, Kroep JR, van der Heijden L, Jutte PC, Hogendoorn PCW, Dijkstra S, Gelderblom H. Adjuvant Zoledronic Acid in High-Risk Giant Cell Tumor of Bone: A Multicenter Randomized Phase II Trial. Oncologist. 2019 Jul;24(7):889-e421. doi: 10.1634/theoncologist.2019-0280. Epub 2019 Apr 30. PMID 31040253