Clinical Trial: Study of the Effect of Zoledronate on Local Recurrence After Surgical Treatment of Giant Cell Tumors of Bone Zométa

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary:

The giant cell tumor (GTC) is an aggressive benign bone tumor, growing at the metaphyseal-epiphyseal regions of long bones, especially around the knee and the distal radius.It is responsible for bony destruction in para-articular zone fracture and leading to the breakdown and destruction of the underlying joint.

Histologically, the tumor cell contains a contingent of monocytic cells round, a contingent of giant type cell of type osteoclastic responsible for bone resorption that accompanies these tumors and a contingent of lengthened cells fibroblast-like considered to be contingent tumor.

The treatment is exclusively surgical; or by resection of the lesion which takes away tumour and its environment, solution which, if it prevents local recurrence, imposes an important bony and articular reconstruction, always limited and deteriorating rapidly over time in these young patients; or by curettage of lesion, by "hollowing-out" of the bone, creating a hole which it will be necessary to fill up by a bony grafting or a substitute of the bone (cement). This last solution, if it preserves a better function, exposes at risk of local recurrence,putting into play the prognosis of articulation near, most often the knee.Despite different local adjuvants treatments used during surgical operation, after having curetted the cavity and before filling it up, the recidivism rates vary from 12 % to 41 % (average 25 %) in literature.

The beneficial effect of the adjuvants therapeutics suggests the concept broadly accepted by a tumoral microscopic residual at the origin of the local recidivism .Biphosphonates (BP) is molecules which settle in vivo on the hydroxyapatite of the bone; they inhibit the recruitment of the osteoclast forerunners and the activity of mature osteoclast. Besides,

Detailed Summary:

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

Sponsor: Nantes University Hospital

Current Primary Outcome: Decrease in the recurrence rate of GTC of the bone after surgery (efficacy). [ Time Frame: 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Tolerance at the filling treatment with zoledronic acid (safety). [ Time Frame: 36 months ]

Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: June 28, 2011
Date Started: January 2006
Date Completion:
Last Updated: August 29, 2013
Last Verified: August 2013