BridgeMD
New treatment option for Hip Fracture
Official title The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery
ClinicalTrials.gov ID: NCT06898814
What this study is testing
What is Ferric Derisomaltose?
Ferric Derisomaltose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hip fracture.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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
- 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
- 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
- Patient declared terminally ill
- Pathologic Fracture
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen NV, Denmark
- Herlev, Denmark
- Odense C, Denmark
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen NV, Denmark; Herlev, Denmark; Odense C, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.