Forskning ved Københavns Universitet - Københavns Universitet


A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Eric Orwoll
  • Christence S Teglbjærg
  • Bente Lomholt Langdahl
  • Roland Chapurlat
  • Edward Czerwinski
  • David L Kendler
  • Jean-Yves Reginster
  • Alan Kivitz
  • E Michael Lewiecki
  • Paul D Miller
  • Michael A Bolognese
  • Michael R McClung
  • Henry G Bone
  • Osten Ljunggren
  • Bo Abrahamsen
  • Ugis Gruntmanis
  • Yu-Ching Yang
  • Rachel B Wagman
  • Suresh Siddhanti
  • Andreas Grauer
  • Og 2 flere
  • Jesse W Hall
  • Steven Boonen
Context: Men with low bone mineral density (BMD) were treated with denosumab. Objective: Our objective was to investigate the effects of denosumab compared with placebo in men with low BMD after 1 yr of treatment. Design, Subjects, and Intervention: This was a placebo-controlled, phase 3 study to investigate the efficacy and safety of denosumab 60 mg every 6 months vs. placebo in men with low BMD. Main Outcome Measure: The primary endpoint was the percent change from baseline in lumbar spine (LS) BMD at month 12. Results: Of the 242 randomized subjects (mean age 65 yr), 228 (94.2%) completed 1 yr of denosumab therapy. After 12 months, denosumab resulted in BMD increases of 5.7% at the LS, 2.4% at the total hip, 2.1% at the femoral neck, 3.1% at the trochanter, and 0.6% at the one third radius (adjusted P ≤ 0.0144 for BMD percent differences at all sites compared with placebo). Sensitivity analyses done by controlling for baseline covariates (such as baseline testosterone levels, BMD T-scores, and 10-yr osteoporotic fracture risk) demonstrated that the results of the primary endpoint were robust. Subgroup analyses indicate that treatment with denosumab was effective across a spectrum of clinical situations. Treatment with denosumab significantly reduced serum CTX levels at d 15 (adjusted P <0.0001). The incidence of adverse events was similar between groups. Conclusions: One year of denosumab therapy in men with low BMD was well tolerated and resulted in a reduction in bone resorption and significant increases in BMD at all skeletal sites assessed.
TidsskriftJournal of Clinical Endocrinology and Metabolism
Udgave nummer9
Sider (fra-til)3161-9
Antal sider9
StatusUdgivet - 2012

ID: 48413834