<br>        Inclusion criteria:<br><br>          -  Prostate cancer with at least one cancer-related bone lesion with or without hormonal<br>             treatment.<br><br>          -  Breast cancer with at least one cancer-related bone lesion<br><br>          -  Negative pregnancy test at screening in case of child-bearing potential and<br>             Performance status ECOG 0-2<br><br>          -  Normal liver and kidney function<br><br>          -  Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have<br>             elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or<br>             bone.<br><br>        Exclusion criteria:<br><br>          -  Prior treatment with bisphosphonates within 6 months before study start, and during<br>             treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other<br>             bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <<br>             8.0 mg/dl (2.00 mmol/L) or =12.0mg/dl (3.00 mmol/L)<br><br>          -  Current/active dental problems including<br><br>          -  infection of the teeth or jawbone<br><br>          -  dental or fixture trauma<br><br>          -  current or previous osteonecrosis of the jaw<br><br>          -  exposed bone in the mouth<br><br>          -  slow healing after dental procedures<br><br>          -  recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)<br><br>          -  Patients with clinically symptomatic brain metastases. Severe physical or<br>             psychological concomitant diseases expected to impair compliance with the provisions<br>             of the study protocol or impair the assessment of drug of patient safety<br><br>          -  Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant<br>             pathologic findings in ECG<br><br>          -  History of diseases with influence on bone metabolism such as Paget´s disease and<br>             primary hyperparathyroidism and with need of treatment for osteoporosis (defined<br>             according to DVO, T-Score =2.5).<br><br>          -  Previous radiation therapy to bone (including therapeutic radioisotopes such as<br>             strontium 89) within 1 month<br><br>        Additional protocol-defined inclusion/exclusion criteria may apply<br>      ;<br>        Inclusion criteria:<br><br>          -  Prostate cancer with at least one cancer-related bone lesion with or without hormonal<br>             treatment.<br><br>          -  Breast cancer with at least one cancer-related bone lesion<br><br>          -  Negative pregnancy test at screening in case of child-bearing potential and<br>             Performance status ECOG 0-2<br><br>          -  Normal liver and kidney function<br><br>          -  Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have<br>             elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or<br>             bone.<br><br>        Exclusion criteria:<br><br>          -  Prior treatment with bisphosphonates within 6 months before study start, and during<br>             treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other<br>             bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <<br>             8.0 mg/dl (2.00 mmol/L) or =12.0mg/dl (3.00 mmol/L)<br><br>          -  Current/active dental problems including<br><br>          -  infection of the teeth or jawbone<br><br>          -  dental or fixture trauma<br><br>          -  current or previous osteonecrosis of the jaw<br><br>          -  exposed bone in the mouth<br><br>          -  slow healing after dental procedures<br><br>          -  recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)<br><br>          -  Patients with clinically symptomatic brain metastases. Severe physical or<br>             psychological concomitant diseases expected to impair compliance with the provisions<br>             of the study protocol or impair the assessment of drug of patient safety<br><br>          -  Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant<br>             pathologic findings in ECG<br><br>          -  History of diseases with influence on bone metabolism such as Paget´s disease and<br>             primary hyperparathyroidism and with need of treatment for osteoporosis (defined<br>             according to DVO, T-Score =2.5).<br><br>          -  Previous radiation therapy to bone (including therapeutic radioisotopes such as<br>             strontium 89) within 1 month<br><br>        Additional protocol-defined inclusion/exclusion criteria may apply<br>      ;<br>        Inclusion criteria:<br><br>          -  Prostate cancer with at least one cancer-related bone lesion with or without hormonal<br>             treatment.<br><br>          -  Breast cancer with at least one cancer-related bone lesion<br><br>          -  Negative pregnancy test at screening in case of child-bearing potential and<br>             Performance status ECOG 0-2<br><br>          -  Normal liver and kidney function<br><br>          -  Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have<br>             elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or<br>             bone.<br><br>        Exclusion criteria:<br><br>          -  Prior treatment with bisphosphonates within 6 months before study start, and during<br>             treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other<br>             bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <<br>             8.0 mg/dl (2.00 mmol/L) or =12.0mg/dl (3.00 mmol/L)<br><br>          -  Current/active dental problems including<br><br>          -  infection of the teeth or jawbone<br><br>          -  dental or fixture trauma<br><br>          -  current or previous osteonecrosis of the jaw<br><br>          -  exposed bone in the mouth<br><br>          -  slow healing after dental procedures<br><br>          -  recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)<br><br>          -  Patients with clinically symptomatic brain metastases. Severe physical or<br>             psychological concomitant diseases expected to impair compliance with the provisions<br>             of the study protocol or impair the assessment of drug of patient safety<br><br>          -  Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant<br>             pathologic findings in ECG<br><br>          -  History of diseases with influence on bone metabolism such as Paget´s disease and<br>             primary hyperparathyroidism and with need of treatment for osteoporosis (defined<br>             according to DVO, T-Score =2.5).<br><br>          -  Previous radiation therapy to bone (including therapeutic radioisotopes such as<br>             strontium 89) within 1 month<br><br>        Additional protocol-defined inclusion/exclusion criteria may apply<br>      ;<br>        Inclusion criteria:<br><br>          -  Prostate cancer with at least one cancer-related bone lesion with or without hormonal<br>             treatment.<br><br>          -  Breast cancer with at least one cancer-related bone lesion<br><br>          -  Negative pregnancy test at screening in case of child-bearing potential and<br>             Performance status ECOG 0-2<br><br>          -  Normal liver and kidney function<br><br>          -  Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have<br>             elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or<br>             bone.<br><br>        Exclusion criteria:<br><br>          -  Prior treatment with bisphosphonates within 6 months before study start, and during<br>             treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other<br>             bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <<br>             8.0 mg/dl (2.00 mmol/L) or =12.0mg/dl (3.00 mmol/L)<br><br>          -  Current/active dental problems including<br><br>          -  infection of the teeth or jawbone<br><br>          -  dental or fixture trauma<br><br>          -  current or previous osteonecrosis of the jaw<br><br>          -  exposed bone in the mouth<br><br>          -  slow healing after dental procedures<br><br>          -  recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)<br><br>          -  Patients with clinically symptomatic brain metastases. Severe physical or<br>             psychological concomitant diseases expected to impair compliance with the provisions<br>             of the study protocol or impair the assessment of drug of patient safety<br><br>          -  Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant<br>             pathologic findings in ECG<br><br>          -  History of diseases with influence on bone metabolism such as Paget´s disease and<br>             primary hyperparathyroidism and with need of treatment for osteoporosis (defined<br>             according to DVO, T-Score =2.5).<br><br>          -  Previous radiation therapy to bone (including therapeutic radioisotopes such as<br>             strontium 89) within 1 month<br><br>        Additional protocol-defined inclusion/exclusion criteria may apply<br>