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Effects of denosumab on bone mineral density and bone turnover in patients with rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates
  1. Robin K Dore (rkdmail{at}sbcglobal.net)
  1. Robin K Dore, MD, Inc., United States
    1. Stanley B Cohen
    1. Metroplex Clinical Research Center, United States
      1. Nancy E Lane
      1. University of California-Davis Medical Center, United States
        1. William R Palmer
        1. Westroads Medical Group, United States
          1. William Shergy
          1. Rheumatology Associates of North Alabama, United States
            1. Lifen Zhou
            1. Amgen Inc., United States
              1. Huei Wang
              1. Amgen Inc., United States
                1. Wayne Tsuji
                1. Amgen Inc., United States
                  1. Richard Newmark
                  1. Amgen Inc., United States

                    Abstract

                    Objectives: We report results of subgroup analyses of bone mineral density (BMD) and bone turnover markers from a randomized, double-blind, placebo-controlled, phase II study of denosumab, an investigational RANKL inhibitor, in patients with rheumatoid arthritis (RA) concurrently receiving treatment with bisphosphonates or glucocorticoids.

                    Methods: Patients received subcutaneous placebo (n=75), denosumab 60mg (n=71), or denosumab 180mg (n=72) at baseline and 6 months. Assessments included dual X-ray absorptiometry scans of the lumbar spine and hip, serum type I C-telopeptide (sCTx-I), and serum procollagen 1N terminal peptide (P1NP).

                    Results: Denosumab treatment increased mean lumbar spine and hip BMD and reduced sCTx-I and P1NP versus placebo through 12 months, regardless of baseline BMD or marker levels or concomitant bisphosphonate or glucocorticoid use.

                    Conclusions: This study extends evidence that denosumab increases BMD and reduces bone turnover in patients with RA and may provide a new therapeutic option for reducing systemic bone loss in patients with RA.

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