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Not yet recruiting NCT07659184

IRONCARE: Iron Treatment in Older Patients With Hip Fractures

Phase IV Interventional Hip Fracture Anemia Iron Placebo - Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ferric Derisomaltose, Oral Iron (Ferrous sulphate), Placebo IV, Placebo Tablets.
Who it may be relevant to
Registry conditions: Hip Fracture, Anemia, Iron, Placebo - Control. Basic parameters: from 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • Drug Ferric Derisomaltose
    Intravenous Ferric Derisomaltose shortly after surgery and placebo 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)
  • Drug Placebo Tablets
    Placebo tablets on alternate days for 90 days

Primary outcome measures

  • Fatigue [Time frame: Baseline and days 30 and 90 after discharge]
  • Hemoglobin increment [Time frame: Baseline and days 30 and 90 after discharge]
  • Safety profile [Time frame: Days 15, 30, 45 and 90 after discharge]
Secondary outcome measures (8)
  • Physical function - NMS [Time frame: Baseline and days 30 and 90 after discharge]
  • Physical function - handgrip strength [Time frame: Baseline and days 30 and 90 after discharge.]
  • Physical function - 30 second sit-to-stand-test [Time frame: Baseline and days 30 and 90 after discharge.]
  • Fear of Falling [Time frame: Days 30 and 90 after discharge]
  • Cognitive impairment [Time frame: Baseline and days 30 and 90 after discharge]
  • Quality of life [Time frame: Baseline and 90 days after discharge]
  • Biochemical iron status - transferrin [Time frame: Baseline and on days 30 and 90 after discharge]
  • Biochemical iron status - ferritin [Time frame: Baseline and on days 30 and 90 after discharge]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 5 centers
  • Aarhus Univeristy Hospital — Aarhus N
  • Regional Hospital Gødstrup — Herning
  • Regional Hospital Horsens — Horsens
  • Regional Hospital Randers — Randers
  • Regional Hospital Viborg — Viborg

Identifiers

NCT: NCT07659184 · IRONCARE-2026 · 2026-526949-94-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗