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The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery
Sponsor: Soren Overgaard
Summary
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.
Official title: The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2025-06-09
Completion Date
2027-09-14
Last Updated
2025-12-10
Healthy Volunteers
No
Conditions
Interventions
Ferric Derisomaltose
The active intervention is a single dose of Ferric Derisomaltose, 20mg/kg body weight, diluted in 100 mL isotonic sodium chloride 0.9%
Saline (NaCl 0,9 %) (placebo)
Single dose of 100 mL isotonic sodium chloride 0.9%
Locations (3)
Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital
Copenhagen NV, Denmark
Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital
Herlev, Denmark
Department of Orthopaedic Surgery, Odense and Svendborg University Hospital
Odense C, Denmark