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
recurrence
secondary:
- clinical: patient interview, clinical examination
- biological Complete blood count, creatinine, serum calcium, phosphate, magnesium
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Decrease in the recurrence rate of GTC of the bone after surgery (efficacy).
36 months
Yes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
04/10-E
NCT01564121
January 2006
January 2011
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