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ClinicalTrials.gov ID

NCT07659184

Lead Sponsor

University of AarhusOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

528Estimated

Last Update Posted

Jun 24, 2026Actual

Start Date

Oct 1, 2026Estimated

Primary Completion Date

Sep 30, 2028Estimated

Completion Date

Sep 30, 2028Estimated

Official Title

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

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).

• Hip Fracture
• Anemia
• Iron
• Placebo - Control

• Ferric Derisomaltose
• Oral Iron (Ferrous sulphate)
• Placebo IV
• Placebo Tablets

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

University of AarhusOTHER

Collaborators

Region MidtJylland DenmarkOTHER

Viborg Regional HospitalOTHER

Gødstrup HospitalOTHER

Aarhus University HospitalOTHER

Randers Regional HospitalOTHER

Regionshospitalet HorsensOTHER

ole.ancker@rm.dk+4551352385

ole.ancker@rm.dk+4551352385

ole.ancker@rm.dk+4551352385

ole.ancker@rm.dk+4551352385