| Exclusion Criteria: | 1) Patients of childbearing potential not practicing adequate contraception.
2) Patients with poor dentition or recent major dental procedures.
3) History of other malignancies other than non-melanoma skin cancer or carcinoma-in-situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years.
4) Overt psychosis or mental disability or otherwise incompetent to give informed consent.
5) Known hypersensitivity to Zometa (zoledronic acid), other bisphosphonates, or to fluvastatin.
6) Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
7) Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction, implants)
8) Active liver disease or unexplained persistent elevation of ALT or AST > 2 times ULN
9) Serum creatine kinase (CK) > 3 times ULN
10) Patients taking concurrent agents that may increase risk of myopathy such as fibric acid derivatives, nicotinic acid, cyclosporine, azole antifungals (itraconazole, ketoconazole, and fluconazole), macrolide antibiotics (erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, delavirdine, cyclosporine, and grapefruit juice.
11) History of alcohol abuse as such condition independently predisposes patients to myopathy. |