Effect of denosumab on inflammation and bone health in active Charcot foot: A phase II randomised controlled trial.

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  • Additional Information
    • Corporate Authors:
      Charcot Foot Quantitative Ultrasound and Denosumab Study (CRUSADES) Investigators
    • Source:
      Publisher: Elsevier Science Pub. Co Country of Publication: United States NLM ID: 9204583 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-460X (Electronic) Linking ISSN: 10568727 NLM ISO Abbreviation: J Diabetes Complications Subsets: MEDLINE
    • Publication Information:
      Original Publication: New York, NY : Elsevier Science Pub. Co., c1992-
    • Subject Terms:
      Diabetes Mellitus, Type 2*/complications ; Diabetes Mellitus, Type 2*/drug therapy ; Diabetic Foot*/complications ; Diabetic Foot*/drug therapy; Adult ; Humans ; Male ; Middle Aged ; Aged ; Female ; Denosumab/adverse effects ; Bone Density ; Inflammation
    • Abstract:
      Aims: We aimed to investigate the effect of denosumab on pedal bone health and clinical resolution in active Charcot foot (CN).
      Methods: This multicentre open-label phase 2 randomised controlled trial recruited adults with diabetes mellitus and active CN within 3 months of onset. Participants were randomised to standard care alone, or with denosumab 60 mg subcutaneously. Denosumab was administered at baseline and again at 6 months, unless foot temperature had normalised (i.e. <2 °C compared to contralateral foot). Co-primary outcomes were change in calcaneal Stiffness Index and foot temperature normalisation over 18 months.
      Results: Twelve participants per group were analysed; mean age 58 ± 11 years, 83 % male and 92 % had type 2 diabetes. Active CN duration was median 8 (IQR 7-12) weeks. Ninety-two percent were Eichenholtz stage 1 and 96 % involved the midfoot. After 1-month, median decline in Stiffness Index was less in the denosumab verses standard care group (0.5 [IQR -1.0 to 3.9] vs -2.8 [-8.5 to -1.0], p = 0.008). At 18-months, 92 % of the denosumab group attained foot temperature normalisation versus 67 % of the standard care group (p = 0.13).
      Conclusions: Denosumab ameliorated the early decline in calcaneal Stiffness Index associated with active CN. However, no difference in normalisation of foot temperature was observed.
      Competing Interests: Declaration of competing interest None.
      (Copyright © 2024 Elsevier Inc. All rights reserved.)
    • Contributed Indexing:
      Keywords: Bone health; Calcaneal quantitative ultrasound; Charcot foot; Denosumab; Diabetes mellitus; Randomised controlled trial
    • Accession Number:
      4EQZ6YO2HI (Denosumab)
    • Publication Date:
      Date Created: 20240315 Date Completed: 20240401 Latest Revision: 20240508
    • Publication Date:
      20240508
    • Accession Number:
      10.1016/j.jdiacomp.2024.108718
    • Accession Number:
      38490126