Hip FracturePhase 4NCT07659184
IRONCARE: Iron Treatment in Older Patients With Hip Fractures
A Phase 4 study testing Ferric Derisomaltose and Oral Iron (Ferrous sulphate) in people with Hip Fracture and Anemia, run by University of Aarhus at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hip Fracture, Anemia, Iron
- What is being tested?
- Ferric Derisomaltose and Oral Iron (Ferrous sulphate)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 528 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Oct 2026to 30 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Merete Gregersen, ph.d. contact
5 sites in 1 country
Denmark5 sites
Aarhus Univeristy Hospital
Aarhus N, 8200
Ole Vincent Ancker, MD, +4551352385, ole.ancker@rm.dk
Regional Hospital Gødstrup
Herning, 7400
Ole Vincent Ancker, MD, +4551352385, ole.ancker@rm.dk
Regional Hospital Horsens
Horsens, 8700
Ole Vincent Ancker, MD, +4551352385, ole.ancker@rm.dk
Regional Hospital Randers
Randers, 8930
Ole Vincent Ancker, MD, +4551352385, ole.ancker@rm.dk
Regional Hospital Viborg
Viborg, 8800
Ole Vincent Ancker, MD, +4551352385, ole.ancker@rm.dk
About this study
Official title: IRONCARE: Iron Treatment in Older Patients With Hip Fractures - A Double-blinded Placebo-controlled Randomized Trial
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).
- Conditions
- Hip Fracture, Anemia, Iron, Placebo - Control
- Being tested
- Ferric Derisomaltose, Oral Iron (Ferrous sulphate), Placebo IV, Placebo Tablets
- Keywords
- Hip fracture, Anemia, iron, Intravenous iron, mobility, fatigue, hemoglobin, RCT, Placebo
- Medical subject headings
- Hip Fractures, Anemia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric DerisomaltoseDrug
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 IVDrug
100 ml Sodium Chloride (NaCl)
Placebo TabletsDrug
Placebo tablets on alternate days for 90 days
| Study group | Role | What they receive |
|---|---|---|
| IV Iron | Active comparator | Intravenous iron once and placebo tablets on alternate days for 90 days Receives: Drug: Ferric Derisomaltose; Drug: Placebo Tablets |
| Oral Iron | Active comparator | Intravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days Receives: Drug: Oral Iron (Ferrous sulphate); Drug: Placebo IV |
| Placebo | Placebo comparator | Intravenous sodium chloride once and placebo tablets on alternate days for 90 days Receives: Drug: Placebo IV; Drug: Placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
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.
Measured: Baseline and days 30 and 90 after discharge
Hemoglobin increment
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
Measured: Baseline and days 30 and 90 after discharge
Safety profile
Measured as the prevalence and severity of adverse events associated with iron treatment
Measured: Days 15, 30, 45 and 90 after discharge
Secondary outcomes (8)
Physical function - NMS
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.
Measured: Baseline and days 30 and 90 after discharge
Physical function - handgrip strength
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.
Measured: Baseline and days 30 and 90 after discharge.
Physical function - 30 second sit-to-stand-test
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.
Measured: Baseline and days 30 and 90 after discharge.
Fear of Falling
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).
Measured: Days 30 and 90 after discharge
Cognitive impairment
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.
Measured: Baseline and days 30 and 90 after discharge
Quality of life
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.
Measured: Baseline and 90 days after discharge
Biochemical iron status - transferrin
p-transferrin (μmol/L) measured by a venous blood sample.
Measured: Baseline and on days 30 and 90 after discharge
Biochemical iron status - ferritin
p-ferritin (μg/L) measured by a venous blood sample
Measured: Baseline and on days 30 and 90 after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 528 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Region MidtJylland Denmark, Viborg Regional Hospital, Gødstrup Hospital, Aarhus University Hospital, Randers Regional Hospital, Regionshospitalet Horsens
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659184
- Sponsor's protocol ID
- IRONCARE-2026
- Other IDs
- 2026-526949-94-00
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon relevant request
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRONCARE: Iron Treatment in Older Patients With Hip Fractures - A Double-blinded Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT07659184
- Acronym / sponsor ID
- IRONCARE-2026
- Conditions
- Hip Fracture, Anemia, Iron, Placebo - Control
- Keywords
- Hip fracture, Anemia, iron, Intravenous iron, mobility, fatigue, hemoglobin, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 528 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Region MidtJylland Denmark, Viborg Regional Hospital, Gødstrup Hospital, Aarhus University Hospital, Randers Regional Hospital, Regionshospitalet Horsens
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV Iron | Active comparator | Drug: Ferric Derisomaltose, Drug: Placebo TabletsIntravenous iron once and placebo tablets on alternate days for 90 days |
| Oral Iron | Active comparator | Drug: Oral Iron (Ferrous sulphate), Drug: Placebo IVIntravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days |
| Placebo | Placebo comparator | Drug: Placebo IV, Drug: Placebo TabletsIntravenous sodium chloride once and placebo tablets on alternate days for 90 days |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric DerisomaltoseIntravenous Ferric Derisomaltose shortly after surgery and placebo tablets on alternate days for 90 days | Drug | IV Iron |
| Oral Iron (Ferrous sulphate)Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery | Drug | Oral Iron |
| Placebo IV100 ml Sodium Chloride (NaCl) | Drug | Oral Iron, Placebo |
| Placebo TabletsPlacebo tablets on alternate days for 90 days | Drug | IV Iron, Placebo |
Primary outcome
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.
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
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes. Upon relevant request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merete Gregersen, ph.d. contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Derisomaltose and Oral Iron (Ferrous sulphate) in people with Hip Fracture and Anemia, run by University of Aarhus at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ole Vincent Ancker, MD (+4551322385, ole.ancker@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: Baseline and days 30 and 90 after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.