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

NCT06898814 | Recruiting Phase 4

• 2 other identifiers: IronHip Trial2024-515116-42-00
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

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.

Conditions

Hip Fracture; Anemia

Keywords

Hip fracture; Anemia; IV Iron; Mobility; Perioperative optimisation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• New Mobility Score (NMS)

  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.

  Measured as the change from baseline (reported as pre-fracture NMS) in the New Mobility Score after 4, 6 and 12 weeks

Secondary Outcomes (12)

• Hemoglobin

  Measured at baseline, 6 and 12 weeks after intervention.

• Red blood cell transfusion requirement

  Measured on postoperative day (POD) 7 and POD 30

• Fatigue, assessed using the Verbal Rating Scale for Fatigue (F-VRS)

  Measured at baseline, 4, 6 and 12 weeks after intervention.

• 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

• 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

Other Outcomes (7)

• A. Cost-effectiveness analysis

  90 days post intervention

• B. Physical Activity

  SENS motion activity monitor measurements will be collected 10 days after the 6-week follow-up.

• C. Hand Grip Strength

  Hand grip strength will be measured at baseline and again at the 6- and 12-week follow-ups.

Study Arms (2)

Active Investigational Medicinal Product

ACTIVE COMPARATOR

Drug: Ferric Derisomaltose

Placebo

PLACEBO COMPARATOR

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

Ferric Derisomaltose DRUG

The active intervention is a single dose of Ferric Derisomaltose, 20mg/kg body weight, diluted in 100 mL isotonic sodium chloride 0.9%

Active Investigational Medicinal Product

Saline (NaCl 0,9 %) (placebo) DRUG

Single dose of 100 mL isotonic sodium chloride 0.9%

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age or older
• Acute proximal femur fracture surgery
• A hemoglobin measurement ≤6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
• Independent prefracture indoor walking ability, indoor NMS ≥ 2
• Ability to speak and understand Danish
• Able to provide informed consent on the participants own behalf

You may not qualify if:

• Known allergy to intravenous iron
• Residing permanently at a nursing home
• Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
• Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
• Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
• Renal replacement therapy
• Severe dementia assessed by physician
• Recent intravenous iron injection, 4 weeks prior to surgery
• Patient declared terminally ill
• Pathologic Fracture

Sponsors & Collaborators

• Musculoskeletal Statistics Unit, The Parker Institute: collaborator
• Svendborg Hospital: collaborator
• Soren Overgaard: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Odense University Hospital: collaborator

Study Sites (3)

Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital

Copenhagen NV, 2400, Denmark

ACTIVE NOT RECRUITING

Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital

Herlev, 2730, Denmark

RECRUITING

Department of Orthopaedic Surgery, Odense and Svendborg University Hospital

Odense C, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Anemia

Interventions

ferric derisomaltose; Sodium Chloride

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Nicolas Tekin Jones, MD

  Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Tekin Jones, MD

CONTACT

+4520491890; nicolas.tekin.jones@regionh.dk

Søren Overgaard, MD, DMSc

CONTACT

soeren.overgaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant: Blinded Primary Investigators: Blinded Coordinating Investigator: Blinded Project Manager: Blinded Database Manager: Not Blinded Obtaining baseline values (dedicated staff): Blinded Department Health Care Prof. (giving intervention): Not blinded Outcome Assessor (dedicated staff): Blinded IronHip steering committee: Blinded Sponsor: Blinded Statistician: Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor, DMSc

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 27, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 14, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication, no end date.
• Access Criteria: Any researcher, affiliated to an established institution

Locations

DK (3)