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

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

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%

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg

  collaborator OTHER

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Musculoskeletal Statistics Unit, The Parker Institute

  collaborator UNKNOWN

• Svendborg Hospital

  collaborator OTHER

• Soren Overgaard

  lead OTHER

Principal Investigators

• Nicolas Tekin Jones, MD · Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-09

Primary Completion

2027-06-01

Completion

2027-09-14

Countries

• Denmark

Study Locations