Abstract
Aim:Zoledronate is approved for use every 3 weeks in men with bone metastases from castrate-resistant prostate cancer (CRPC) but the basis for such frequency is unclear.Methods:In men with bone metastasis from CRPC we measured the markers of bone turnover - urine and serum telopeptides before the first injection of zoledronate and at four 3-weekly intervals thereafter. Men received further zoledronate treatment after 12 weeks, or earlier if the telopeptides did not meet predefined adequate suppression. The primary end point was the proportion of evaluable subjects with suppressed telopeptides at 12 weeks. Exploratory analyses evaluated predictors of bone turnover suppression and quality-of-life.Results:31 patients were enrolled. Median age was 70 (range: 53–86) years. 65%, (95% CI: 46–81%) had suppressed telopeptides at 12 weeks. Prior skeletal-related events, chemotherapy, bone surgery and higher baseline levels of telopeptides were associated with shorter duration of telopeptides.Conclusion:12-weekly zoledronate suppresses bone turnover in the majority of men with bone metastasis from CRPC.
Highlights
Summary points r Zoledronic acid (ZA) delays skeletal-related events in men with prostate cancer and bone metastases. It is currently approved for use every 3 or 4 weeks. r ZA is associated with adverse effects such as necrosis of the jaw, renal impairment and hypocalcemia. r Given the long half-life of ZA, we aimed to investigate the proportion of men with suppressed urine and serum telopeptides at 12 weeks after first injection of ZA. r We found that a majority of men had suppressed levels of uNTX and sCTX at 12 weeks after one injection of ZA; there was no change in quality of life in men during this period. r Most men need less frequent injections of ZA and further studies need to select men who require less versus more frequent injections
Results of studies looking at appropriate frequency of treatment with other bone targeted agents like denosumab (NCT02051218) [9] are awaited
Summary
Zoledronate is approved for use every 3 weeks in men with bone metastases from castrate-resistant prostate cancer (CRPC) but the basis for such frequency is unclear. It is currently approved for use every 3 or 4 weeks. R ZA is associated with adverse effects such as necrosis of the jaw, renal impairment and hypocalcemia. R Given the long half-life of ZA, we aimed to investigate the proportion of men with suppressed urine and serum telopeptides at 12 weeks after first injection of ZA. R We found that a majority of men had suppressed levels of uNTX and sCTX at 12 weeks after one injection of ZA; It is currently approved for use every 3 or 4 weeks. r ZA is associated with adverse effects such as necrosis of the jaw, renal impairment and hypocalcemia. r Given the long half-life of ZA, we aimed to investigate the proportion of men with suppressed urine and serum telopeptides at 12 weeks after first injection of ZA. r We found that a majority of men had suppressed levels of uNTX and sCTX at 12 weeks after one injection of ZA;
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