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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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
Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
Time frame: every four (4) weeks
Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13
Time frame: every four (4) weeks
Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits.
Time frame: 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.
Time frame: 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
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Huntsman Cancer Institute Univ. of Utah
Salt Lake City, Utah, United States
University of Vermont Fletcher Allen Health Care
Burlington, Vermont, United States
Virginia Cancer Institute Virginia Cancer Center
Richmond, Virginia, United States