IRONCARE: Iron Treatment in Older Patients With Hip Fractures (NCT07659184) | Clinical Trial Compass
Not Yet RecruitingPhase 4
IRONCARE: Iron Treatment in Older Patients With Hip Fractures
Denmark528 participantsStarted 2026-10-01
Plain-language 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).
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue
Timeframe: Baseline and days 30 and 90 after discharge
2
Hemoglobin increment
Timeframe: Baseline and days 30 and 90 after discharge