Clinical trial NCT06898814: The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery
Official title: The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hip Fracture
Anemia
Keywords: Hip fracture
Anemia
IV Iron
Mobility
Perioperative optimisation
Randomized Controlled Trial
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: University Hospital Bispebjerg and Frederiksberg
name: Copenhagen University Hospital at Herlev
name: Odense University Hospital
name: Musculoskeletal Statistics Unit, The Parker Institute
name: Svendborg Hospital
First posted: 2025-03-27
Enrollment: 210
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.


Eligibility criteria: Inclusion Criteria:

1. 65 years of age or older
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:

1. Known allergy to intravenous iron
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

Primary outcomes:
measure: New Mobility Score (NMS)
timeFrame: Measured as the change from baseline (reported as pre-fracture NMS) in the New Mobility Score after 4, 6 and 12 weeks
Secondary outcomes:
measure: Hemoglobin
timeFrame: Measured at baseline, 6 and 12 weeks after intervention.
measure: Red blood cell transfusion requirement
timeFrame: Measured on postoperative day (POD) 7 and POD 30
measure: Fatigue, assessed using the Verbal Rating Scale for Fatigue (F-VRS)
timeFrame: Measured at baseline, 4, 6 and 12 weeks after intervention.
measure: Quality of life with EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L )
timeFrame: Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention
measure: EuroQol Visual Analogue Scale (EQ VAS 0-100)
timeFrame: Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention
measure: Fear of falls measured with, Short Falls Efficacy Scale International (Short-FES-I)
timeFrame: Measured at baseline and at 6 and 12 weeks after intervention.
measure: 30 second Sit-to-Stand-Test (STS)
timeFrame: Measured at baseline, 6 and 12 weeks
measure: Activity of daily living, asessed with Barthel Index 20
timeFrame: Measured as a retrograde baseline and at 6 and 12 weeks after intervention
measure: Pain, assessed using the Verbal Rating Scale for pain
timeFrame: Measured at baseline and at 6 and 12 weeks after intervention
measure: Days alive and at home up to 30 (DAH30)
timeFrame: Measured at 6 weeks after intervention.
measure: Serious adverse event (SAE)
timeFrame: Will be assessed up to the 6 weeks follow up
measure: Mortality
timeFrame: 90 days
Other outcomes:
measure: A. Cost-effectiveness analysis
timeFrame: 90 days post intervention
measure: B. Physical Activity
timeFrame: SENS motion activity monitor measurements will be collected 10 days after the 6-week follow-up.
measure: C. Hand Grip Strength
timeFrame: Hand grip strength will be measured at baseline and again at the 6- and 12-week follow-ups.
measure: D. Knee Extension Strength
timeFrame: Knee extension strength will be measured at baseline and at 6- and 12-week follow-ups.
measure: E. Cognition assessed using, Orientation-Memory-Concentration test (OMC)
timeFrame: Measured at baseline, week 6 and 12 post-intervention.
measure: F. Ferritin Levels as a Measure of Iron Status
timeFrame: Measured at baseline and week 6 and 12 post intervention.
measure: G: Transferrin Saturation as a Measure of Iron Status
timeFrame: Transferrin saturation will be measured at baseline, and at the 6- and 12-week follow-ups.
Locations:
city: Copenhagen NV
country: Denmark
facility: Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital
city: Herlev
country: Denmark
facility: Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital
city: Odense C
country: Denmark
facility: Department of Orthopaedic Surgery, Odense and Svendborg University Hospital
Study officials:
affiliation: Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology
name: Nicolas Tekin Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: