Trial Information
A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Efficacy and Safety
Inclusion Criteria
Inclusion criteria:
- Documented bone metastases from breast cancer, prostate cancer or multiple myeloma
- Prior treatment with zoledronic acid for 1-2 yrs
- Life expectancy of at least 6 months
Exclusion criteria:
- Prior treatment with bisphosphonates other than zoledronic acid
- Abnormal kidney function
- Current or previous dental problems or planned dental surgery
- Pregnant or likely to become pregnant during the study
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs).
Outcome Time Frame:
52 weeks
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmeceuticals
Authority:
Australia: Therapeutic Goods Administration
Study ID:
CZOL446EAU22
NCT ID:
NCT00434447
Start Date:
December 2006
Completion Date:
Related Keywords:
- Bone Neoplasms
- Prostate Cancer
- Breast Cancer
- Multiple Myeloma
- Zoledronic acid
- Bone metastases
- Skeletal Related Events (SREs)
- Renal Impairment
- Osteonecrosis of the Jaw (ONJ)
- Bone involvement
- Multiple Myeloma (MM)
- Bone Neoplasms
- Breast Neoplasms
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasm Metastasis
- Bone Marrow Diseases