IRONCARE: Iron Treatment in Older Patients With Hip Fractures

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Oral Iron (Ferrous sulphate): Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery

Placebo IV: 100 ml Sodium Chloride (NaCl)

Placebo Tablets: Placebo tablets on alternate days for 90 days

Study 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).

Eligibility

Primary outcome measure(s)

• Fatigue — 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.
• Hemoglobin increment — 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
• Safety profile — Days 15, 30, 45 and 90 after discharge
  Measured as the prevalence and severity of adverse events associated with iron treatment

Trial sites (5)

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