{
  "abstract": "Introduction Half of all patients with a hip fracture (HF) do not recover their pre-fracture mobility after 1 year. Mobility and functional capabilities may be impaired by postoperative low haemoglobin levels and iron deficiency. The primary objective of this trial is to compare the effect of a single postoperative dose of ferric derisomaltose 20 mg/kg body weight relative to placebo on the recovery of functional mobility in patients.Methods and analysis The IronHip trial is a multicentre, randomised, double-blind, placebo-controlled trial with participants allocated in a 1:1 ratio to receive intravenous iron or placebo. The eligible population is participants aged 65 years or older who have undergone HF surgery and have a haemoglobin concentration below 105 g/L measured between postoperative day 1 and 5. In total, 210 participants will be randomised. Main analyses will be conducted in the intention-to-treat population using a mixed model for repeated measures, including assessments at baseline and at 4, 6 and 12 weeks after randomisation. Treatment effects will be estimated from the treatment-by-time interaction and reported as between-group differences in least-squares mean New Mobility Score with 95% CIs. The secondary outcomes are haemoglobin, red blood cell transfusions, fatigue, quality of life, self-rated health, fear of falls, 30 s sit-to-stand test, activities of daily living, pain, days alive and at home up to 30 days, mortality and serious adverse events. Exploratory outcomes are cost-effectiveness, physical activity, hand grip strength, knee extension strength, cognition, ferritin and transferrin saturation. Recruitment was initiated on 9 June 2025.Ethics and dissemination The IronHip trial has been approved by the Danish Medicines Agency and the Danish Medical Research Ethics Committee. The protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines, the Declaration of Helsinki and the Good Clinical Practice guidelines. The trial findings will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement in peer-reviewed journals.Registration details EU CT number: 2024–5 15 116-42-00, authorised 9 February 2025.Clinicaltrials.gov: NCT06898814",
  "authors": [
    {
      "affiliations": [
        "Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Capital Region of Denmark, Denmark",
        "Faculty of Health and Medical Sciences, University of Copenhagen Department of Clinical Medicine, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Nicolas Tekin Jones"
    },
    {
      "affiliations": [
        "Faculty of Health and Medical Sciences, University of Copenhagen Department of Clinical Medicine, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Physical and Occupational Therapy, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Morten Tange Kristensen"
    },
    {
      "affiliations": [
        "Section for Biostatistics and Evidence-Based Research, The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Frederiksberg, Capital Region of Denmark, Denmark",
        "Research Unit of Rheumatology, University of Southern Denmark Department of Clinical Research, Odense, Region Syddanmark, Denmark",
        "Cochrane Denmark and Centre for Evidence-Based Medicine Odense (CEBMO), University of Southern Denmark, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Robin Christensen"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital Herlev and Gentofte, Copenhagen, Denmark"
      ],
      "name": "Jens Peter Alva-Jørgensen"
    },
    {
      "affiliations": [
        "Faculty of Health and Medical Sciences, University of Copenhagen Department of Clinical Medicine, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Physical and Occupational Therapy, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Anja Løve Berger"
    },
    {
      "affiliations": [
        "Department of Geriatric and Palliative Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark"
      ],
      "name": "Mark Andreas Eggertsen"
    },
    {
      "affiliations": [
        "Faculty of Health and Medical Sciences, University of Copenhagen Department of Clinical Medicine, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Anaesthesiology, Copenhagen University Hospital - Amager and Hvidovre, Copenhagen, Denmark"
      ],
      "name": "Nicolai Bang Foss"
    },
    {
      "affiliations": [
        "Faculty of Health and Medical Sciences, University of Copenhagen Department of Clinical Medicine, Copenhagen, Capital Region of Denmark, Denmark",
        "Section for Biostatistics and Evidence-Based Research, The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Frederiksberg, Capital Region of Denmark, Denmark"
      ],
      "name": "Marius Henriksen"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Thomas Giver Jensen"
    },
    {
      "affiliations": [
        "Centre for Innovative Medical Technology, University of Southern Denmark, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Kristian Kidholm"
    },
    {
      "affiliations": [
        "Faculty of Health and Medical Sciences, University of Copenhagen Department of Clinical Medicine, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Anaesthesiology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark"
      ],
      "name": "Troels Haxholdt Lunn"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark"
      ],
      "name": "Mads Suhr Nielsen"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Capital Region of Denmark, Denmark",
        "Faculty of Health and Medical Sciences, University of Copenhagen Department of Clinical Medicine, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Henrik Palm"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital Herlev and Gentofte, Copenhagen, Denmark"
      ],
      "name": "Pelle Baggesgaard Petersen"
    },
    {
      "affiliations": [
        "Department of Geriatric and Palliative Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark"
      ],
      "name": "Helene Stampe"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark",
        "University of Southern Denmark Department of Clinical Research, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Bjarke Viberg"
    },
    {
      "affiliations": [
        "Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Capital Region of Denmark, Denmark",
        "Faculty of Health and Medical Sciences, University of Copenhagen Department of Clinical Medicine, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Søren Overgaard"
    },
    {
      "affiliations": [
        "Faculty of Health and Medical Sciences, University of Copenhagen Department of Clinical Medicine, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Geriatric and Palliative Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark"
      ],
      "name": "Martin Aasbrenn"
    }
  ],
  "title": "The effects of intravenous iron on mobility in older adults following hip fracture surgery: protocol for a multicentre, parallel group, randomised controlled trial – the IronHip trial",
  "uid": "ef1261e9-212c-5caf-bb3c-97d110413044"
}