Adjuvant zoledronic acid in ‘high risk’ Giant Cell Tumour of bone (GCT) - A randomized phase II study - - HR-GCT

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005841-50-NL

Enrollment

Registered

2008-10-01

Start date

2008-11-17

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high risk Giant Cell Tumour of bone MedDRA version: 9.1 Level: LLT Classification code 10005970 Term: Bone giant cell tumour benign

Interventions

Trade Name: Zometa Product Name: Zometa Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: ZOLEDRONIC ACID CAS Number: 118072938 Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

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 joint/soft tissue •GCT grade III •Pathological fracture in GCT •absence of local adjuvant therapy -WHO performance status 0 - 2 -Neutrophils > 1.5x109/L, platelets > 100x109/L, and Hb > 6 mmol/l -Bilirubin level 60 cc/min -Expected adequacy of follow-up. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of ‘high risk’ GCT as compared to standard care;Secondary Objective: Determine the relapse free survival. Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT ;Primary end point(s): 2 year recurrence rate	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026