The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Hip Fracture, Anemia

In brief

The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture The main questions it aims to answer are: It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration. The primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the New Mobility Score. Participants will: \- Receive either a single dose of intravenous FDI (20 mg/kg body weight) (and saline) or placebo (saline) at 1-5 days after surgery. This trial will be conducted at three hospitals in Denmark, involving an anticipated 210 participants.

Key facts

Study ID

NCT06898814

Run by

Soren Overgaard

People needed

210

Starts

2025-06-09

Expected to finish

2027-09-14

Last updated by the study team

2026-06-01

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital — Herlev, Denmark (enrolling)
• Department of Orthopaedic Surgery, Odense and Svendborg University Hospital — Odense C, Denmark (enrolling)
• Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital — Copenhagen NV, Denmark

Full record on ClinicalTrials.gov

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