NCT06898814

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

The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Soren Overgaard · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Fracture
• Anemia

Interventions

Type	Name	Description
DRUG	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%
DRUG	Saline (NaCl 0,9 %) (placebo)	Single dose of 100 mL isotonic sodium chloride 0.9%

Timeline

• Start date: 2025-06-09
• Primary completion: 2027-06-01
• Completion: 2027-09-14
• First posted: 2025-03-27
• Last updated: 2025-12-10

Locations

3 sites across 1 country: Denmark