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Phase 2 Study of the Effect of Zoledronate on Local Recurrence After Surgical Treatment of Giant Cell Tumors of Bone

Phase 1/Phase 2
18 Years
Not Enrolling
Giant Cell Tumors of Bone

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Trial Information

Phase 2 Study of the Effect of Zoledronate on Local Recurrence After Surgical Treatment of Giant Cell Tumors of Bone

Outcome Measures:

- Main: occurrence of recurrence detectable by Reasonable Magnetic Imaging (IRM) and / or
standardized radiography.

Local recurrence will be discussed in the presence or appearance on the radiographic and IRM
monitoring of an osteolysis in the periphery of the cavity curetted, does not exist on the
radio in post-operative with IRM signal abnormalities in the same location,taking the
gadolinium. If in doubt, a new surgical biopsy will confirm or not the diagnosis of local


- clinical: patient interview, clinical examination

- biological Complete blood count, creatinine, serum calcium, phosphate, magnesium

Inclusion Criteria:

- Patient age (18 years)

- Benign giant cell tumor of the bone histologically confirmed after biopsy

- Non-metastatic tumor

- The first surgical treatment of the tumor

- Indication of conservative treatment with curettage, filling asked by the surgeon

- Written consent of the patient

Exclusion Criteria:

- Minor patient

- Location of a pulmonary TCG

- Surgical indication of prior or immediately en bloc resection

- Need for treatment with an aminoglycoside

- Against-indication for zoledronic acid: pregnancy, lactation, known hypersensitivity
to this drug or another bisphosphonate, severe renal impairment or a previous kidney
failure, severe bradycardia or conduction disturbance on ECG.

- Dental Problems in progress, including an infection of the teeth or jaw underlying
(mandible and maxilla), dental trauma or recent diagnosis or history of
osteo-necrosis of the jaw (ONJ)​​, or exposure of the OSE or delayed healing after
dental procedures.

- Dental or jaw bone recent (within 6 weeks) or planned (extractions, implants, ...).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Decrease in the recurrence rate of GTC of the bone after surgery (efficacy).

Outcome Time Frame:

36 months

Safety Issue:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2006

Completion Date:

January 2011

Related Keywords:

  • Giant Cell Tumors of Bone
  • Bone Neoplasms
  • Giant Cell Tumors
  • Recurrence
  • Giant Cell Tumor of Bone