Abstract
Denosumab is an anti-receptor activator of nuclear factor (NF)-kappaB (RANK) ligand human monoclonal antibody studied as a treatment for postmenopausal osteoporosis (PMO) and bone destruction due to rheumatoid arthritis (RA) or metastatic cancers. As of February 2009, the candidate was undergoing US Food and Drug Administration review, and might be approved by October 2009. Late phase clinical trials demonstrated that denosumab possesses a similar safety profile to bisphosphonates and that it can be either equally or more effective than bisphosphonates at preventing bone loss due to PMO, RA or cancer treatment and metastases.
MeSH terms
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Animals
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Antibodies, Monoclonal / adverse effects
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Antibodies, Monoclonal / therapeutic use*
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Antibodies, Monoclonal, Humanized
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Arthritis, Rheumatoid / drug therapy*
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Arthritis, Rheumatoid / immunology
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Arthritis, Rheumatoid / physiopathology
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Bone Neoplasms / drug therapy*
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Bone Neoplasms / immunology
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Bone Neoplasms / secondary
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Bone Resorption / prevention & control
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Breast Neoplasms / drug therapy*
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Breast Neoplasms / immunology
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Breast Neoplasms / pathology
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Clinical Trials as Topic
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Denosumab
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Drug Approval
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Female
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Humans
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Osteoporosis, Postmenopausal / drug therapy*
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Osteoporosis, Postmenopausal / immunology
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Osteoporosis, Postmenopausal / physiopathology
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RANK Ligand / adverse effects
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RANK Ligand / therapeutic use*
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United States
Substances
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Antibodies, Monoclonal
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Antibodies, Monoclonal, Humanized
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RANK Ligand
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Denosumab