Intravenous iron to help people regain mobility after hip fracture surgery
The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial
This trial will test whether a single infusion of intravenous iron given soon after hip fracture surgery helps people aged 65 and older regain their walking ability.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 3 sites (Copenhagen NV and 2 other locations) |
| Trial ID | NCT06898814 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people 65 or older who had hip fracture surgery, have postoperative hemoglobin ≤10.5 g/dL within 1–5 days, were independently walking indoors before the fracture, speak Danish, and can give consent.
Not a fit: Patients without postoperative anemia or with contraindications to IV iron (such as iron-overload disorders, severe liver disease, recent IV iron, permanent nursing-home residency, or severe dementia) are unlikely to benefit.
Why it matters
Potential benefit: If successful, the treatment could speed recovery of walking ability, raise hemoglobin, and reduce fatigue after hip fracture surgery.
How similar studies have performed: Previous surgical and orthopedic trials have shown perioperative IV iron reliably increases hemoglobin but have produced mixed results on improving functional recovery and mobility.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Copenhagen NV and 2 other locations
- Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital — Copenhagen NV, Denmark (Recruiting)
- 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)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.