Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer - On Going Clinical Trials for Prostate Cancer Drugs

Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Supportive care

Active

18 and over

Pharmaceutical / Industry

CZOL446EDE28
NCT00334139

Trial Description

Summary

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Novartis Study Chair

Novartis Basel Ph: 41 61 324 1111

Trial Sites

Germany

Ulm