Status:
COMPLETED
Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 purpos...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT00334139
Start Date
May 1 2006
End Date
July 1 2009
Last Update
February 7 2017
Active Locations (1)
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1
Novartis Investigative Site
Ulm, Germany