IRONCARE: Iron Treatment in Older Patients With Hip Fractures

NCT07659184 | Not Yet Recruiting Phase 4

• 2 other identifiers: IRONCARE-20262026-526949-94-00
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Hip Fracture; Anemia; Iron; Placebo - Control

Keywords

Hip fracture; Anemia; iron; Intravenous iron; mobility; fatigue; hemoglobin; RCT; Placebo

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Physical function - NMS

  Baseline and days 30 and 90 after discharge

• Physical function - handgrip strength

  Baseline and days 30 and 90 after discharge.

• Physical function - 30 second sit-to-stand-test

  Baseline and days 30 and 90 after discharge.

• Fear of Falling

  Days 30 and 90 after discharge

• Cognitive impairment

  Baseline and days 30 and 90 after discharge

Study Arms (3)

IV Iron

ACTIVE COMPARATOR

Intravenous iron once and placebo tablets on alternate days for 90 days

Drug: Ferric Derisomaltose; Drug: Placebo Tablets

Oral Iron

ACTIVE COMPARATOR

Intravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days

Drug: Oral Iron (Ferrous sulphate); Drug: Placebo IV

Placebo

PLACEBO COMPARATOR

Intravenous sodium chloride once and placebo tablets on alternate days for 90 days

Drug: Placebo IV; Drug: Placebo Tablets

Interventions

Ferric Derisomaltose DRUG

Intravenous Ferric Derisomaltose shortly after surgery and placebo tablets on alternate days for 90 days

IV Iron

Oral Iron (Ferrous sulphate) DRUG

Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery

Oral Iron

Placebo IV DRUG

100 ml Sodium Chloride (NaCl)

Oral Iron; Placebo

Placebo Tablets DRUG

Placebo tablets on alternate days for 90 days

IV Iron; Placebo

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Region MidtJylland Denmark: collaborator
• Viborg Regional Hospital: collaborator
• Gødstrup Hospital: collaborator
• Aarhus University Hospital: collaborator
• Randers Regional Hospital: collaborator
• Regionshospitalet Horsens: collaborator

Study Sites (5)

Aarhus Univeristy Hospital

Aarhus N, 8200, Denmark

Location

Regional Hospital Gødstrup

Herning, 7400, Denmark

Location

Regional Hospital Horsens

Horsens, 8700, Denmark

Location

Regional Hospital Randers

Randers, 8930, Denmark

Location

Regional Hospital Viborg

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Hip Fractures; Anemia; Fatigue

Interventions

ferric derisomaltose; Iron; ferrous sulfate

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Ole Vincent Ancker, MD

CONTACT

+4551322385; ole.ancker@rm.dk

Merete Gregersen, ph.d.

CONTACT

meregreg@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

DK (5)