The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery

Phase 4

Not yet recruiting

• Conditions: Hip Fracture; Anemia
• Interventions: Drug: Ferric Derisomaltose; Drug: Saline (NaCl 0,9 %) (placebo)

• Registration Number: NCT06898814
• Lead Sponsor: Soren Overgaard

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Study Start: 2025-05-15
• Primary Completion: 2027-04-01
• Study Completion: 2027-07-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Investigational Medicinal Product	Ferric Derisomaltose	-
Placebo	Saline (NaCl 0,9 %) (placebo)	-

Primary Outcome Measures

Name	Time	Method
New Mobility Score (NMS)	Measured as the change from baseline (reported as pre-fracture NMS) in the New Mobility Score after 4, 6 and 12 weeks	The primary outcome is to compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility measured with New Mobility Score. New Mobility Score is a validated patient reported outcome measurement 0-9-point score for hip fracture patients, with 9 point equal to a fully independent indoor, outdoor and during shopping walking ability and 0 point, indicating no walking ability. Higher scores indicate a better outcome.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin	Measured at baseline, 6 and 12 weeks after intervention.
Red blood cell transfusion requirement	Measured on postoperative day (POD) 7 and POD 30	This will be measured by the proportion of patients who receive at least one red blood cell unit and the amounts of units per patient
Fatigue, assessed using the Verbal Rating Scale for Fatigue (F-VRS)	Measured at baseline, 4, 6 and 12 weeks after intervention.	Fatigue will be assessed using the Verbal Rating Scale for Fatigue (F-VRS). This scale, ranging from 0 to 4, measures fatigue in hip fracture patients, where 0 indicates no fatigue and 4 represents extreme fatigue.
Quality of life with EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L )	Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention	The EQ-5D-5L questionnaire measures health-related quality of life across five dimensions, with scores ranging from 1 (no problems) to 5 (extreme problems). Higher scores indicate worse outcomes, reflecting greater health issues.
EuroQol Visual Analogue Scale (EQ VAS 0-100)	Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention	The EQ VAS 0-100 (range) is a visual analogue scale where 0 represents the worst imaginable health state and 100 represents the best. Higher scores on the EQ VAS indicate a better health outcome.
Fear of falls measured with, Short Falls Efficacy Scale International (Short-FES-I)	Measured at baseline and at 6 and 12 weeks after intervention.	Short Falls Efficacy Scale International (Short-FES-I) measures concern about falling during various activities, with scores ranging from 7 (no concern about falling) to 28 (severe concern about falling). Higher scores indicate greater concern about falling.
30 second Sit-to-Stand-Test (STS)	Measured at baseline, 6 and 12 weeks	Participants are encouraged to stand and fully sit as many times as possible within 30 seconds, with correct form monitored by the tester. If a participant uses their arms, they score a 0, and only correctly executed stands are counted. This test assesses a wide range of ability levels. Lower score indicates worse outcome.
Activity of daily living, asessed with Barthel Index 20	Measured as a retrograde baseline and at 6 and 12 weeks after intervention	Barthel 20 Index measures a patient's level of independence in daily activities, with scores ranging from 0 (complete dependence) to 20 (complete independence). Higher scores indicate a better outcome, reflecting greater independence.
Pain, assessed using the Verbal Rating Scale for pain	Measured at baseline and at 6 and 12 weeks after intervention	Hip fracture-related pain will be assessed using the Verbal Rating Scale for Pain, which ranges from 0 to 4. A score of 0 indicates no pain, while a score of 4 represents unbearable or the worst imaginable pain
Days alive and at home up to 30 (DAH30)	Measured at 6 weeks after intervention.	The DAH30 is determined using a combination of electronic medical records (obtaining length of stay) and direct participant inquiries at the 6 week follow up
Serious adverse event (SAE)	Will be assessed up to the 6 weeks follow up	SAE defined following the ICH - GCP guidelines
Mortality	90 days	The time of death is determined using validated registry-based data, from which survival rates, as well as 30-day and 90-day mortality rates, are calculated.

Trial Locations

Locations (3)

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