The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorSoren Overgaard
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Known allergy to intravenous iron
Residing permanently at a nursing home
Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
Trial design
Treatments tested in this trial
- Ferric Derisomaltose
- Saline (NaCl 0,9 %) (placebo)
Treatment groups
210 Participants
are divided into 2 treatment groupsSponsors and collaborators
Soren Overgaard
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor institution
University Hospital Bispebjerg and Frederiksberg
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Odense University Hospital
Collaborator
Musculoskeletal Statistics Unit, The Parker Institute
Collaborator
Svendborg Hospital
Collaborator
Source ClinicalTrials.gov