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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark
Hmikek Hywpsevk	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.01.2025

Trial locations

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.

Investigated diseases:

Hip fracture

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 ID:

2024-515116-42-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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