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NCT Number: NCT07659184

IRONCARE: Iron Treatment in Older Patients With Hip Fractures

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).

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Key information

Conditions

Hip Fracture Anemia Fatigue Femoral Fractures Fractures, Bone Hematologic Diseases Hemic and Lymphatic Diseases Hip Fractures Hip Injuries Iron Leg Injuries Pathological Conditions, Signs and Symptoms Placebo - Control Signs and Symptoms Wounds and Injuries

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus Univeristy Hospital, Aarhus N, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferric derisomaltose

Drug

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

Oral Iron (Ferrous sulphate)

Drug

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

Placebo IV

Drug

100 ml Sodium Chloride (NaCl)

Placebo tablets

Drug

Placebo tablets on alternate days for 90 days

Primary outcomes

  1. Fatigue

    Time frame: Baseline and days 30 and 90 after discharge

    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.

  2. Hemoglobin increment

    Time frame: Baseline and days 30 and 90 after discharge

    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

  3. Safety profile

    Time frame: Days 15, 30, 45 and 90 after discharge

    Measured as the prevalence and severity of adverse events associated with iron treatment

Secondary outcomes

  1. Physical function - NMS

    Time frame: Baseline and days 30 and 90 after discharge

    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.

  2. Physical function - handgrip strength

    Time frame: Baseline and days 30 and 90 after discharge.

    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.

  3. Physical function - 30 second sit-to-stand-test

    Time frame: Baseline and days 30 and 90 after discharge.

    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.

  4. Fear of Falling

    Time frame: Days 30 and 90 after discharge

    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).

  5. Cognitive impairment

    Time frame: Baseline and days 30 and 90 after discharge

    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). A low score indicates impaired cognition.

    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.

  6. Quality of life

    Time frame: Baseline and 90 days after discharge

    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.

  7. Biochemical iron status - transferrin

    Time frame: Baseline and on days 30 and 90 after discharge

    p-transferrin (μmol/L) measured by a venous blood sample.

  8. Biochemical iron status - ferritin

    Time frame: Baseline and on days 30 and 90 after discharge

    p-ferritin (μg/L) measured by a venous blood sample

Study contacts

Contact information is provided by the study sponsor or research team.

Merete Gregersen, ph.d.

CONTACT

[email protected]

Ole Vincent Ancker, MD

CONTACT

[email protected]

+4551322385

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Gødstrup Hospital
  • Randers Regional Hospital
  • Region MidtJylland Denmark
  • Regionshospitalet Horsens
  • Viborg Regional Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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