IRONCARE: Iron Treatment in Older Patients With Hip Fractures

IRONCARE: Iron Treatment in Older Patients With Hip Fractures - A Double-blinded Placebo-controlled Randomized Trial

The aim of this study is to investigate the effects of intravenous (IV) iron therapy compared to alternate-day oral iron treatment and no supplementation in older patients with hip fractures. This study will examine the impact of iron treatment on fatigue, functional decline, fear of falling, cognitive impairment, and quality of life, as well as its effects on iron stores and hemoglobin levels, with the overall goal of improving postoperative rehabilitation.

The trial will be conducted on five different hospitals in the Central Region of Denmark (Region Midtjylland).

Study Overview

• Status: Not yet recruiting
• Conditions: Anemia; Hip Fracture; Iron; Placebo - Control
• Intervention / Treatment: Drug: Ferric Derisomaltose; Drug: Placebo Tablets; Drug: Oral Iron (Ferrous sulphate); Drug: Placebo IV

• Study Type: Interventional
• Enrollment (Estimated): 528
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ole Vincent Ancker, MD; Phone Number: +4551322385; Email: ole.ancker@rm.dk
• Study Contact Backup: Name: Merete Gregersen, ph.d.; Email: meregreg@rm.dk

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Univeristy Hospital
    • Contact: Ole Vincent Ancker, MD; Phone Number: +4551352385; Email: ole.ancker@rm.dk
  • Herning, Denmark, 7400
    • Regional Hospital Gødstrup
    • Contact: Ole Vincent Ancker, MD; Phone Number: +4551352385; Email: ole.ancker@rm.dk
  • Horsens, Denmark, 8700
    • Regional Hospital Horsens
    • Contact: Ole Vincent Ancker, MD; Phone Number: +4551352385; Email: ole.ancker@rm.dk
  • Randers, Denmark, 8930
    • Regional Hospital Randers
    • Contact: Ole Vincent Ancker, MD; Phone Number: +4551352385; Email: ole.ancker@rm.dk
  • Viborg, Denmark, 8800
    • Regional Hospital Viborg
    • Contact: Ole Vincent Ancker, MD; Phone Number: +4551352385; Email: ole.ancker@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hip fracture (ICD-10 codes: DS720, DS721 and DS722)
• Low energy trauma
• Age ≥ 75 years
• Hemoglobin ≤7.0 mmol/L (11 g/dL) during hospital admission

Exclusion Criteria:

• Pathological fracture
• Periprosthetic fracture
• Inability to understand or speak Danish
• Dysphagia and thus inability to swallow study medication
• Signs of iron overload, hemochromatosis, or hemosiderosis
• Liver disease (cirrhosis or hepatitis) and transaminase levels >3 times upper limit of normal
• Known allergy to iron formulations
• Severe asthma
• Severe hypophosphatemia: <0.35 mmol/L
• Patients already receiving iron supplementation that cannot be paused for the study period
• Cognitive impairment that results in either memantine-treatment or a Short Portable Mental Status Questionnaire (SPMSQ) score > 4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV Iron; Intravenous iron once and placebo tablets on alternate days for 90 days	Drug: Ferric Derisomaltose; Intravenous Ferric Derisomaltose shortly after surgery and placebo tablets on alternate days for 90 days; Drug: Placebo Tablets; Placebo tablets on alternate days for 90 days
Active Comparator: Oral Iron; Intravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days	Drug: Oral Iron (Ferrous sulphate); Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery; Drug: Placebo IV; 100 ml Sodium Chloride (NaCl)
Placebo Comparator: Placebo; Intravenous sodium chloride once and placebo tablets on alternate days for 90 days	Drug: Placebo Tablets; Placebo tablets on alternate days for 90 days; Drug: Placebo IV; 100 ml Sodium Chloride (NaCl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Measured by Multidimensional Fatigue Inventory tool (MFI-20). MFI-20 is a questionnaire of 20 questions answered on a 5-point scale from "yes, that is true" (1 point) to "no, that is not true" (5 points). A higher score indicates greater severity of fatigue.	Baseline and days 30 and 90 after discharge
Hemoglobin increment	Defined as a change of level of a minimum of 1.24 mmol/L (2 g/dL). The level of hemoglobin will be measured with a venous blood sample	Baseline and days 30 and 90 after discharge
Safety profile	Measured as the prevalence and severity of adverse events associated with iron treatment	Days 15, 30, 45 and 90 after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical function - NMS	New Mobility score (NMS) is used to assess the participant's mobility. The participant will be asked three questions ranging from "no difficult and no walking aid" (3 points) to "not able to at all" (0 points). The score ranges from 0 - 9 points. A higher score indicates a higher level of independent mobility.	Baseline and days 30 and 90 after discharge
Physical function - handgrip strength	Handgrip strength is measured by using a dynamometer that measures the pressure made from a hand grip on the dynamometer in kilograms. A higher score indicates higher handgrip strength.	Baseline and days 30 and 90 after discharge.
Physical function - 30 second sit-to-stand-test	30 second sit-to-stand-test is used as a parameter for strength, muscle power and dynamic balance. The test is performed by placing a chair with the back against a wall. The participant must be seated on the chair with their arms crossed and are then encouraged to fully stand and sit as many times as possible in 30 seconds. If the arms are used to stand, the score will be 0. A low score indicates low physical ability, and a higher score indicates high physical ability.	Baseline and days 30 and 90 after discharge.
Fear of Falling	Measured by Short Fall Efficiency Scale-International which is a 7 questions questionnaire assessing the fear of falling from 7 points (low concern of falling) to 28 points (high concern of falling).	Days 30 and 90 after discharge
Cognitive impairment	Measured by Brief Assessment of Impaired Cognition (BASIC). The tool consists of three questions to the patient (0-6 points), word finding (0-5 points), categorized recalling of photos (0-8 points) and lastly three questions to a next of kin (0-6 points). In cases where no next of kins is available the conversion table is used of an estimated score according to the guidance from the Danish Dementia Research Centre.	Baseline and days 30 and 90 after discharge
Quality of life	European Quality of Life - 5 Dimensions (EQ-5D-5L) which is a standardized questionnaire used to evaluate health-related quality of life. There are 5 questions ranging from level 1 - 5 Level 1 indicates: no problems Level 2 indicates: slight problems Level 3 indicates: moderate problems Level 4 indicates: severe problems Level 5 indicates: extreme problems And lastly a visual analogue scale from 0 - 100 where 100 means the best health imaginable and 0 means the worst health imaginable.	Baseline and 90 days after discharge
Biochemical iron status	p-ferritin and p-transferrin measured by a venous blood sample	Baseline and on days 30 and 90 after discharge

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Gødstrup Hospital; Regionshospitalet Horsens; Viborg Regional Hospital; Region MidtJylland Denmark; Randers Regional Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: fatigue; hemoglobin; Anemia; RCT; mobility; Placebo; iron; Hip fracture; Intravenous iron
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Hematologic Diseases; Fractures, Bone; Femoral Fractures; Hip Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Fatigue; Hip Fractures; Anemia; Inorganic Chemicals; Elements; Metals; Metals, Heavy; Transition Elements; Iron; ferrous sulfate; ferric derisomaltose
• Other Study ID Numbers: IRONCARE-2026; 2026-526949-94-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon relevant request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No