| Zoledronic
acid prevents bone complications in patients with metastatic prostate
cancer The bisphosphonate zoledronic acid is effective for treatment of bone complications in patients with metastatic prostate cancer, according to data presented at the annual meeting of the American Urological Association. Bone complications (also called skeletal related events) include bone pain, pathologic fractures, need for radiation or surgery to bone, spinal cord compression, and hypercalcaemia. This study marks the first time a bisphosphonate has demonstrated efficacy in treating bone metastases in this patient population. "Bone metastases can result
in debilitating pain, fractures and compression of the spine and
are a significant problem for patients with advanced prostate cancer.
Until now, there were few effective therapies available for these
patients," said Fred Saad, M.D. "Zometa R (zoledronic
acid) represents a significant advance in the overall treatment
of advanced prostate cancer patients and should be a welcome addition
for urologists and oncologists in the care of their patients."
Researchers found that significantly fewer drug patients experienced any skeletal related event (33 percent of drug patients versus 44 percent of placebo patients). In addition, fewer patients on zoledronic acid had a pathologic fracture (13 percent of drug patients versus 22 percent of placebo patients). Patients in the active drug group also showed a slower rate of progression of pain. All patients experienced a mean increase from baseline in composite Brief Pain Inventory pain scores over time; however, the increases were lower at every time point for patients treated with zoledronic acid compared with those on placebo (difference statistically significant at months three and nine). In multiple clinical trials
involving patients with bone metastases, zoledronic acid was generally
well tolerated, with a safety profile similar to other intravenous
bisphosphonates. The most commonly reported adverse events included
flu-like syndrome, fatigue, gastrointestinal reactions, anemia,
weakness, cough, dyspnea, and edema. All bisphosphonates have been
associated with reports of renal insufficiency. Patients should
have serum creatinine assessed prior to receiving each drug dose,
and caution is advised when zoledronic acid is administered with
other potentially nephrotoxic drugs. Due to the risk of clinically
significant deterioration in renal function, single doses should
not exceed 4 mg and the duration of infusion should be no less than
15 minutes. |