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      Therapeutics and Clinical Risk Management (submit here)

      This international, peer-reviewed Open Access journal by Dove Medical Press focuses on reporting of clinical studies, outcomes and safety in all therapeutic areas and surgical intervention areas. Sign up for email alerts here.

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      Zoledronic acid in the management of metastatic bone disease


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          Many patients with advanced cancer experience decreased bone strength due to metastatic foci, underlying osteoporosis and/or cancer treatment induced bone loss. The clinical consequences of metastatic disease involving the skeleton are widespread. This review focuses on the efficacy, pharmacology, and safety when using intravenous biphosphonate such a zoledronic acid for cancer bone metastases. Zoledronic acid is the gold standard for the medical management of metastatic bone disease. The indications for treatment include prevention of skeletal relevant events (SRE), osteoporotic complications, and palliation of bone pain, among others. Zoledronic acid is the only bisphosphonate effective in decreasing SREs associated with bone metastases from advanced renal cell carcinoma and prostate cancer. Regarding prostate cancer, zoledronic acid effectively prevents both bone loss in patients with locally advanced disease receiving androgen deprivation therapy and SREs in men with hormone-refractory or hormone-sensitive metastatic disease. Zoledronic acid has an acceptable safety profile and tolerability, and has been effective at significantly decreasing the incidence, delaying the onset, and reducing the overall risk of experiencing an SRE compared to placebo. It is the only bisphosphonate currently approved for the prevention and treatment of skeletal complications in patients with bone metastases due to all solid tumors.

          Most cited references54

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          The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer.

          We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases. Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n=248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE. There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively. SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.
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            Predictive value of bone resorption and formation markers in cancer patients with bone metastases receiving the bisphosphonate zoledronic acid.

            Three large, randomized trials of patients with bone metastases recently demonstrated that zoledronic acid reduces the risk of skeletal-related events. These trials provide an opportunity for investigating the correlation between bone metabolism and clinical outcome during bisphosphonate therapy. Urinary measurements of N-telopeptide (Ntx) and serum bone alkaline phosphatase (BAP) were obtained in 1,824 bisphosphonate-treated patients-1,462 with zoledronic acid (breast, 490; prostate, 411; myeloma, 210; non-small-cell lung, 183; other, 168) and 362 with pamidronate (breast, 254; myeloma, 108). This exploratory cohort analysis grouped patients by baseline and most recent levels of Ntx as low ( or = 100 nmol/mmol creatinine), and BAP as low ( or = 146 U/L). The relative risks for negative clinical outcomes were estimated for each group using multiple-event and Cox regression models with time-varying covariates. Patients with high and moderate Ntx levels had 2-fold increases in their risk of skeletal complications and disease progression compared with patients with low Ntx levels (P < .001 for all). High Ntx levels in each solid tumor category were associated with a 4- to 6-fold increased risk of death on study, and moderate Ntx levels a 2- to 4-fold increased risk compared with low Ntx levels (P < .001 for all). Bone alkaline phosphatase also showed some correlation with risk of negative clinical outcomes. The bone resorption marker Ntx provides valuable prognostic information in patients with bone metastases receiving bisphosphonates.
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              Metastatic renal cell carcinoma.

              Patients with renal cell cancer (RCC) develop metastatic spread in approximately 33% of cases. The clinical management of patients with metastatic RCC is complicated by the lack of significant efficacy from available therapies. Common sites of metastases include the lung, liver, bone, brain, and adrenal gland, with case reports detailing the capacity of RCC to appear almost anywhere in the body. More than one organ system is often involved in the metastatic process. Metastases may be found at diagnosis or at some interval after nephrectomy. Approximately 20% to 50% of patients will eventually develop metastatic disease after nephrectomy. A shorter interval between nephrectomy and the development of metastases is associated with a poorer prognosis. Patients with metastatic RCC face a dismal prognosis, with a median survival time of only 6 to 12 months and a 2-year survival rate of 10% to 20%. Recent advances in biologic response modifier therapy have brought new hope to a small percentage of patients who respond to this therapy and rekindled interest in cytoreductive nephrectomy as an integral part of the management of these patients.

                Author and article information

                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                February 2008
                February 2008
                : 4
                : 1
                : 261-268
                Duke Prostate Center and Division of Urologic Surgery, Duke University Medical Center Durham, NC, USA
                Author notes
                Correspondence: Thomas J Polascik Division of Urologic Surgery, Duke University, Box 2804 Yellow Zone, Durham, NC 27710, USA Tel +1 919 684 4946 Fax +1 919 684 5220 Email polas001@ 123456mc.duke.edu
                © 2008 Dove Medical Press Limited. All rights reserved

                metastatic bone disease,zoledronic acid,skeletal relevant events,advanced prostate cancer,osteoporosis


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