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The effects of intravenous iron on mobility in elderly patients following hip fracture surgery: a multicentre, parallel group, randomised, controlled trial
EU CTIS ID: 2024-515116-42-00
What this study is testing
The primary objective is to compare the effect of a single dose of 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 (NMS) after 6 weeks
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 65 years of age or older
- - Acute proximal femur fracture surgery
- - A haemoglobin 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 their own behalf
You likely can't join if
- - No known allergy to intravenous iron
- - Patient declared terminal ill
- - Pathologic Fracture
- - Residing permanently at a nursing home
- - Haematological 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
See the full eligibility criteria
- - 65 years of age or older
- - Acute proximal femur fracture surgery
- - A haemoglobin 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 their own behalf
- - No known allergy to intravenous iron
- - Patient declared terminal ill
- - Pathologic Fracture
- - Residing permanently at a nursing home
- - Haematological 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
- - Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
- - Plasma sodium levels below 125 or above 150 mmol/L on the day of inclusion
- - Renal replacement therapy
- - Severe dementia assessed by physician
- - Recent intravenous iron injection, 4 weeks prior to surgery
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.