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Bone is the most common site of metastases in prostate cancer and bone complications cause substantial morbidity to this population. Phase III studies have shown that zoledronic acid is effective in decreasing the morbidity associated with bone metastases. Zoledronic acid (ZA) is generally well tolerated but may have side effects such as hypocalcemia, renal impairment and osteonecrosis of the jaw. Administration of ZA as infrequently as once yearly is sufficient to prevent osteopenia or osteoporosis. The optimal treatment interval is unknown, but the drug is often empirically administered every 3-4 weeks. The cost of such treatment is high, and the risk of exposing patients (especially those at low risk) to potential serious side effects with uncertain benefit warrants investigation. This study will determine the duration of suppression of bone turnover in prostate cancer patients with bone metastases following a single infusion of Zoledronic Acid and its effect on quality of life.
Full description
The bone is the most common site of metastasis in men with prostate cancer, and that bone metastases are associated with a significant risk of SREs. Prevention and delay in onset of SREs has been demonstrated with use of ZA. The optimal dosing frequency of ZA is not known in this population but it is usually given every 3-4 weeks, whereas injections as infrequently as once yearly protect from bone loss in patients without bone metastases who are receiving ADT. uNTX, sCTX and BAP are markers of bone turnover and bone formation that are suppressed in response to ZA and are associated with the likelihood of development of an SRE. In this study, we propose to determine the duration of suppression of bone turnover (all uNTX, sCTX and BAP) in response to a single dose of ZA in patients with castration resistant prostate cancer metastatic to bone.
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