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RECRUITING
NCT06898814
PHASE4

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

Sponsor: Soren Overgaard

View on ClinicalTrials.gov

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

Interventions

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%

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