Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer
Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer
Bisphosphonates have been used extensively in the treatment and the prevention of skeletal
 complications associated with bone metastases in patients with breast cancer and prostate
 cancer.

 The purpose of this study is to assess the effect of zoledronic acid patients with prostate
 cancer or breast cancer and bone metastasis.
Inclusion criteria:

 -  Prostate cancer with at least one cancer-related bone lesion with or without hormonal
 treatment.

 -  Breast cancer with at least one cancer-related bone lesion

 -  Negative pregnancy test at screening in case of child-bearing potential and
 Performance status ECOG 0-2

 -  Normal liver and kidney function

 -  Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have
 elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or
 bone.

 Exclusion criteria:

 -  Prior treatment with bisphosphonates within 6 months before study start, and during
 treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other
 bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <
 8.0 mg/dl (2.00 mmol/L) or ≥12.0mg/dl (3.00 mmol/L)

 -  Current/active dental problems including

 -  infection of the teeth or jawbone

 -  dental or fixture trauma

 -  current or previous osteonecrosis of the jaw

 -  exposed bone in the mouth

 -  slow healing after dental procedures

 -  recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)

 -  Patients with clinically symptomatic brain metastases. Severe physical or
 psychological concomitant diseases expected to impair compliance with the provisions
 of the study protocol or impair the assessment of drug of patient safety

 -  Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant
 pathologic findings in ECG

 -  History of diseases with influence on bone metabolism such as Paget´s disease and
 primary hyperparathyroidism and with need of treatment for osteoporosis (defined
 according to DVO, T-Score ≤2.5).

 -  Previous radiation therapy to bone (including therapeutic radioisotopes such as
 strontium 89) within 1 month

 Additional protocol-defined inclusion/exclusion criteria may apply