Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Effects of Ferric Derisomaltose on Mobility in Elderly Patients After Hip Fracture Surgery

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on understanding how a treatment with ferric derisomaltose, a type of iron given through a vein, affects the ability to move in older adults who have had surgery for a hip fracture. The study will compare the effects of a single dose of this iron treatment to a placebo. The main goal is to see how well patients recover their ability to move around after six weeks.

Participants in the study will receive either the iron treatment or a placebo. The treatment involves a single dose of ferric derisomaltose given through an injection or infusion. The study will track the recovery of movement by checking the New Mobility Score (NMS), which measures how well someone can move around. This will be assessed at different times: by phone at four weeks and in person at six and twelve weeks after the treatment.

In addition to movement recovery, the study will also look at other factors such as blood levels of hemoglobin, the need for blood transfusions, feelings of tiredness, quality of life, fear of falling, and pain related to the hip fracture. These will be measured at the start of the study and again at six and twelve weeks after the treatment. The study will also monitor any serious side effects and check on the participants' overall health and survival up to 90 days after joining the study.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is determined based on age (65 years or older), recent hip fracture surgery, specific haemoglobin levels, and ability to walk indoors before the fracture.

    Participants must be able to speak and understand Danish and provide informed consent.

  2. Step 2

    Initial assessment

    Pre-fracture mobility is assessed using the New Mobility Score (NMS).

    Baseline measurements include haemoglobin levels, fatigue, quality of life, fear of falls, daily living activities, pain, and a 30-second sit-to-stand test.

  3. Step 3

    Treatment administration

    A single dose of ferric derisomaltose (20 mg per kg of body weight) is administered through an intravenous injection or infusion.

    The solution used for the injection or infusion is sodium chloride.

  4. Step 4

    Follow-up assessments

    Mobility recovery is assessed at 4 weeks by phone and in-person at 6 and 12 weeks using the NMS.

    Haemoglobin levels are checked at 6 and 12 weeks.

    Fatigue, quality of life, fear of falls, daily living activities, pain, and the sit-to-stand test are evaluated at 6 and 12 weeks.

    The need for red blood cell transfusions is recorded on postoperative days 7 and 30.

  5. Step 5

    Final evaluation

    The primary endpoint is the change in NMS after 6 weeks.

    Secondary endpoints include haemoglobin levels, transfusion requirements, fatigue, quality of life, fear of falls, daily living activities, pain, days alive and at home, serious adverse events, and mortality at 30 and 90 days.

Who can join the trial?

6 criteria

  • Must be **65 years of age or older**.
  • Must have had **surgery for a hip fracture** in the upper part of the thigh bone.
  • Must have a **haemoglobin level** of **6.5 mmol/L (10.5 g/dL) or less** within 1 to 5 days after surgery. Haemoglobin is a protein in red blood cells that carries oxygen.
  • Must have been able to **walk indoors independently** before the fracture, with a **New Mobility Score (NMS) of 2 or more**. The New Mobility Score is a way to measure how well someone can move around.
  • Must be able to **speak and understand Danish**.
  • Must be able to **give informed consent** by themselves. This means they understand the study and agree to participate.

Who cannot join the trial?

3 criteria

  • Patients who have a **hip fracture** cannot participate. A hip fracture is a break in the upper part of the thigh bone near the hip joint.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified in the provided data.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

FDI is an intravenous iron treatment used in this trial. It is given to patients who have undergone hip fracture surgery. The goal of using this medication is to help improve the patients' ability to move around and perform daily activities. The trial aims to see if a single dose of this iron treatment can enhance recovery and improve mobility in elderly patients.

What is already known about the treatment

Intravenous Iron – This medication is administered through an injection directly into the bloodstream. It is currently being studied in clinical trials to assess its effects on mobility in elderly patients after hip fracture surgery. The main therapeutic indication is to improve recovery of functional mobility in these patients. At the molecular level, intravenous iron works by replenishing iron stores in the body, which is essential for the production of hemoglobin and red blood cells, thereby improving oxygen transport and energy levels. It is classified as an iron supplement in pharmacology.

Investigated diseases

Hip Fracture – A hip fracture is a break in the upper part of the thigh bone (femur) near the hip joint. It often occurs in older adults due to falls or weakened bones from conditions like osteoporosis. The fracture can cause severe pain and difficulty moving the leg, making it hard to stand or walk. Over time, the injury can lead to reduced mobility and independence, as well as complications if not properly managed. Recovery involves regaining strength and function in the affected leg, which can be a gradual process. Rehabilitation focuses on improving mobility and the ability to perform daily activities.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-515116-42-00Estimated enrolment210 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.