Actively Recruiting
The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery
Led by Soren Overgaard · Updated on 2025-12-10
210
Participants Needed
3
Research Sites
118 weeks
Total Duration
On this page
Sponsors
S
Soren Overgaard
Lead Sponsor
U
University Hospital Bispebjerg and Frederiksberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 65 years of age or older
- Acute proximal femur fracture surgery
- Hemoglobin measurement �3-6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
- Independent prefracture indoor walking ability, indoor New Mobility Score �3-2 or higher
- Ability to speak and understand Danish
- Able to provide informed consent on the participant's own behalf
You will not qualify if you...
- Known allergy to intravenous iron
- Residing permanently at a nursing home
- Hematological conditions with risk of iron overload such as haemochromatosis or hemosiderosis, or requiring alternative treatments like hematological malignancies
- Other contraindications to iron treatment, including severe liver cirrhosis and hepatitis
- Severe uncontrolled infection such as bacteraemia or sepsis
- Plasma sodium levels below 125 or above 150 mmol/L on the day of inclusion
- Receiving renal replacement therapy
- Severe dementia as assessed by a physician
- Recent intravenous iron injection within 4 weeks prior to surgery
- Patient declared terminally ill
- Pathologic fracture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital
Copenhagen NV, Denmark, 2400
Actively Recruiting
2
Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital
Herlev, Denmark, 2730
Actively Recruiting
3
Department of Orthopaedic Surgery, Odense and Svendborg University Hospital
Odense C, Denmark, 5000
Actively Recruiting
Research Team
N
Nicolas Tekin Jones, MD
CONTACT
S
Søren Overgaard, MD, DMSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here