The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery
NCT ID: NCT06898814
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
210 participants
INTERVENTIONAL
2025-06-09
2027-09-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Investigational Medicinal Product
Ferric Derisomaltose
The active intervention is a single dose of Ferric Derisomaltose, 20mg/kg body weight, diluted in 100 mL isotonic sodium chloride 0.9%
Placebo
Saline (NaCl 0,9 %) (placebo)
Single dose of 100 mL isotonic sodium chloride 0.9%
Interventions
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Ferric Derisomaltose
The active intervention is a single dose of Ferric Derisomaltose, 20mg/kg body weight, diluted in 100 mL isotonic sodium chloride 0.9%
Saline (NaCl 0,9 %) (placebo)
Single dose of 100 mL isotonic sodium chloride 0.9%
Eligibility Criteria
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Inclusion Criteria
2. Acute proximal femur fracture surgery
3. A hemoglobin measurement ≤6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
4. Independent prefracture indoor walking ability, indoor NMS ≥ 2
5. Ability to speak and understand Danish
6. Able to provide informed consent on the participants own behalf
Exclusion Criteria
2. Residing permanently at a nursing home
3. Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
4. Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
5. Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
6. Plasma sodium levels below 125 or above 150 mmol/L on the day of inclusion
7. Renal replacement therapy
8. Severe dementia assessed by physician
9. Recent intravenous iron injection, 4 weeks prior to surgery
10. Patient declared terminally ill
11. Pathologic Fracture
65 Years
ALL
No
Sponsors
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Soren Overgaard
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Copenhagen University Hospital at Herlev
OTHER
Odense University Hospital
OTHER
Musculoskeletal Statistics Unit, The Parker Institute
UNKNOWN
Svendborg Hospital
OTHER
Responsible Party
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Soren Overgaard
Clinical Professor, DMSc
Principal Investigators
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Nicolas Tekin Jones, MD
Role: PRINCIPAL_INVESTIGATOR
Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology
Locations
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Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital
Copenhagen NV, , Denmark
Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital
Herlev, , Denmark
Department of Orthopaedic Surgery, Odense and Svendborg University Hospital
Odense C, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-515116-42-00
Identifier Type: CTIS
Identifier Source: secondary_id
IronHip Trial
Identifier Type: -
Identifier Source: org_study_id
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