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      Long-term treatment of osteoporosis: safety and efficacy appraisal of denosumab

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          Abstract

          Denosumab is a fully human monoclonal antibody to the receptor activator of nuclear factor-κB ligand (RANKL), a member of the tumor necrosis factor receptor superfamily essential for osteoclastogenesis. Denosumab treatment is associated with a rapid, sustained, and reversible reduction in bone turnover markers, a continuous marked increase in bone mineral density at all sites, and a marked decrease in the risk of vertebral, hip, and nonvertebral fractures in women with postmenopausal osteoporosis. Therefore, it could be considered as an effective alternative to previous bisphosphonate treatment as well as first-line treatment of severe osteoporosis. Cost-effectiveness studies support this suggestion. In addition, denosumab seems to be the safest treatment option in patients with impaired renal function. Denosumab is characterized by reversibility of its effect after treatment discontinuation, in contrast with bisphosphonates. Large-scale clinical trials, including the extension of FREEDOM trial for up to 5 years, are reassuring for its safety. However, given its brief post-market period, vigilance regarding adverse events related to putative RANKL inhibition in tissues other than bone, as well as those related to bone turnover oversuppression, is advised.

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          Author and article information

          Journal
          Ther Clin Risk Manag
          Ther Clin Risk Manag
          Therapeutics and Clinical Risk Management
          Therapeutics and Clinical Risk Management
          Dove Medical Press
          1176-6336
          1178-203X
          2012
          2012
          19 June 2012
          : 8
          : 295-306
          Affiliations
          [1 ]Department of Endocrinology, 424 General Military Hospital, Thessaloniki
          [2 ]Second Medical Clinic, Medical School, Aristotle University of Thessaloniki, Ippokration Hospital, Thessaloniki
          [3 ]Department of Pharmacology, 424 General Military Hospital, Thessaloniki
          [4 ]Department of Endocrinology and Diabetes, 251 Hellenic Air Force and VA General Hospital, Athens, Greece
          Author notes
          Correspondence: Athanasios D, Anastasilakis, Soulini 4, 566 25 Sykies, Greece, Tel +30 23 1038 1697, Fax +30 23 1038 1010, Email anastath@ 123456endo.gr
          Article
          tcrm-8-295
          10.2147/TCRM.S24239
          3387828
          22767993
          © 2012 Anastasilakis et al, publisher and licensee Dove Medical Press Ltd.

          This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

          Categories
          Review

          Medicine

          efficacy, denosumab, fracture, safety, adverse event, osteoporosis

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