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This phase 3 randomised controlled trial was designed to test whether 12-weekly zoledronate is non-inferior to 4-weekly zoledronate in terms of the risk of skeletal events. The study population comprised… Click to show full abstract
This phase 3 randomised controlled trial was designed to test whether 12-weekly zoledronate is non-inferior to 4-weekly zoledronate in terms of the risk of skeletal events. The study population comprised 1822 patients with metastatic bone disease from prostate cancer (38%), breast cancer, or myeloma. There was no significant difference in the proportion of patients experiencing a skeletal event within 2 yr: 29% for 12-weekly versus 30% for 4-weekly treatment. The lower limit of the 95% confidence interval for the difference in risk was 4%, compared to the prespecified non-inferiority margin of 7%, indicating that 12-weekly treatment is non-inferior to 4weekly treatment.
Journal Title: European urology
Year Published: 2018
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