Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year
- Registration Number
- NCT00424983
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Male or female between 18-75 years of age
- Multiple myeloma or breast cancer with bone involvement
- Treatment with zoledronic acid for bone lesions between 10-15 months prior to entry into study with a total of 9-20 infusions received.
- Current active dental problems or recent (within 8 weeks) or planned dental or jaw surgery
- Active or uncontrolled infection, liver, or renal disease
- History of treatment with intravenous bisphosphonates
- Diagnosis of metabolic bone disorders other than osteoporosis (e.g. Paget's disease)
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zometa q 4 weeks Zoledronic acid - Zometa q 12 weeks Zoledronic acid -
- Primary Outcome Measures
Name Time Method Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17 every four (4) weeks Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13 every four (4) weeks
- Secondary Outcome Measures
Name Time Method Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits. every four (4) weeks Efficacy outcomes will be measured throughout the study by number and time to skeletal related events (determined by bone surveys and bone scans) as well as the measurement of pain and analgesic scores. bone survey = every 12 weeks; bone scan = every 24 weeks; pain & analgesic scores = weekly prior to visit 8 (inclusive), every 4 weeks after visit 8
Trial Locations
- Locations (7)
Oncotherapeutics
🇺🇸West Hollywood, California, United States
Rocky Mountain Cancer Centers RMCC
🇺🇸Greenwood Village, Colorado, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Vermont Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Huntsman Cancer Institute Univ. of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia Cancer Institute Virginia Cancer Center
🇺🇸Richmond, Virginia, United States