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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital
RECRUITING
Copenhagen Nv
Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital
RECRUITING
Herlev
Department of Orthopaedic Surgery, Odense and Svendborg University Hospital
NOT_YET_RECRUITING
Odense C
Contact Information
Primary
Nicolas Tekin Jones, MD
nicolas.tekin.jones@regionh.dk
+4520491890
Backup
Søren Overgaard, MD, DMSc
soeren.overgaard@regionh.dk
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2027-09-14
Participants
Target number of participants: 210
Treatments
Active_comparator: Active Investigational Medicinal Product
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Soren Overgaard
Collaborators: University Hospital Bispebjerg and Frederiksberg, Musculoskeletal Statistics Unit, The Parker Institute, Odense University Hospital, Svendborg Hospital, Copenhagen University Hospital at Herlev

This content was sourced from clinicaltrials.gov

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