Intravenous iron to help people regain mobility after hip fracture surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 4 trial gives a single dose of ferric derisomaltose (20 mg/kg) or saline 1–5 days after hip fracture surgery to about 210 patients across three Danish hospitals. The primary outcome is change in the New Mobility Score from pre-fracture baseline, with secondary measures including hemoglobin, fatigue, and markers of skeletal muscle recovery over weeks to months. Eligible participants are aged 65 or older, had acute proximal femur fracture surgery, have postoperative hemoglobin ≤10.5 g/dL, and were independently walking indoors before the fracture. The trial tests whether early correction of iron deficiency improves functional recovery after hip fracture.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 65 years of age or older
2. Acute proximal femur fracture surgery
3. A hemoglobin measurement ≤6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
4. Independent prefracture indoor walking ability, indoor NMS ≥ 2
5. Ability to speak and understand Danish
6. Able to provide informed consent on the participants own behalf

Exclusion Criteria:

1. Known allergy to intravenous iron
2. Residing permanently at a nursing home
3. Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
4. Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
5. Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
6. Plasma sodium levels below 125 or above 150 mmol/L on the day of inclusion
7. Renal replacement therapy
8. Severe dementia assessed by physician
9. Recent intravenous iron injection, 4 weeks prior to surgery
10. Patient declared terminally ill
11. Pathologic Fracture

Where it's running

• Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital
  Herlev, Denmark Recruiting
• Department of Orthopaedic Surgery, Odense and Svendborg University Hospital
  Odense C, Denmark Recruiting
• Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital
  Copenhagen NV, Denmark Active not recruiting

Study contacts

• Principal investigator: Nicolas Tekin Jones, MD — Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology
• Study coordinator: Nicolas Tekin Jones, MD
• Email: nicolas.tekin.jones@regionh.dk
• Phone: +4520491890

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.