Postdose symptoms were defined as any adverse experience occurring up to 3 days after an infusion. The five most common postdose symptoms were pyrexia, myalgia, flu-like symptoms, headache, and arthralgia. There was “a dramatic decline in the rate of postdose symptoms with the second and third infusions, compared with the first,” Dr. Black said.
Short-term renal safety was monitored by measuring serum creatinine levels at days 9–11 in more than 4,000 subjects. There were transient rises in serum creatinine but in only a very small number of patients. All of the rises resolved, and patients were redosed at their next infusion. Based on these results and other measures of renal safety, the researchers concluded that zoledronic acid infusions had no cumulative impact on renal function.
In terms of cardiac safety, atrial fibrillation was more common in the women on zoledronic acid (1.2%) than in the women on placebo (0.4%). In electrocardiogram studies of 559 women at 9–11 days following the third infusion, there were no differences between the two groups.
There were no spontaneous adverse event reports of osteonecrosis of the jaw. The researchers also searched the database for terms related to the condition. Using the definition “exposed bone in the mouth for longer than 6 weeks,” three cases were identified—two subjects on placebo and one subject on zoledronic acid. All three healed with antibiotic treatment.
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