Hip FracturePhase 4IronHipNCT06898814
The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery
A Phase 4 study testing Ferric Derisomaltose in people with Hip Fracture and Anemia, run by Soren Overgaard at 3 sites in Denmark.
Trial summary
The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture The main questions it aims to answer are: It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture, Anemia
- What is being tested?
- Ferric Derisomaltose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 3 sitesDenmark
- Study dates
- 9 Jun 2025to 14 Sep 2027
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years of age or older
- Acute proximal femur fracture surgery
- A hemoglobin measurement ≤6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
- Independent prefracture indoor walking ability, indoor NMS ≥ 2
- Ability to speak and understand Danish
- Able to provide informed consent on the participants own behalf
Who cannot join
- Known allergy to intravenous iron
- Residing permanently at a nursing home
- Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
- Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
- Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
- Plasma sodium levels below 125 or above 150 mmol/L on the day of inclusion
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- Renal replacement therapy
- Severe dementia assessed by physician
- Recent intravenous iron injection, 4 weeks prior to surgery
- Patient declared terminally ill
- Pathologic Fracture
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Søren Overgaard, MD, DMSc contact
Denmark3 sites, 2 recruiting
- Active, not recruiting
Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital
Copenhagen NV, 2400
- Recruiting
Department of Orthopedic Surgery and Traumatology, Herlev, Copenhagen University Hospital
Herlev, 2730
Jens Peter Alva-Jørgensen, MD, + 45 3868 3868, Jens.Peter.Alva-Joergensen@regionh.dk
Nicolas Tekin Jones, MD, +4520491890, nicolas.tekin.jones@regionh.dk
- Recruiting
Department of Orthopaedic Surgery, Odense and Svendborg University Hospital
Odense C, 5000
Bjarke Viberg, MD, PhD, Professor, + 45 3868 3868, bjarke.viberg@rsyd.dk
Nicolas Tekin Jones, MD, +4520491890, nicolas.tekin.jones@regionh.dk
About this study
Official title: The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial
The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture
The main questions it aims to answer are:
Read more
It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration.
The primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the New Mobility Score.
Participants will:
- Receive either a single dose of intravenous FDI (20 mg/kg body weight) (and saline) or placebo (saline) at 1-5 days after surgery.
This trial will be conducted at three hospitals in Denmark, involving an anticipated 210 participants.
- Conditions
- Hip Fracture, Anemia
- Being tested
- Ferric Derisomaltose, Saline (NaCl 0,9 %) (placebo)
- Keywords
- Hip fracture, Anemia, IV Iron, Mobility, Perioperative optimisation, Randomized Controlled Trial
- Medical subject headings
- Hip Fractures, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric DerisomaltoseDrug
The active intervention is a single dose of Ferric Derisomaltose, 20mg/kg body weight, diluted in 100 mL isotonic sodium chloride 0.9%
Saline (NaCl 0,9 %) (placebo)Drug
Single dose of 100 mL isotonic sodium chloride 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Active Investigational Medicinal Product | Active comparator | Not described Receives: Drug: Ferric Derisomaltose |
| Placebo | Placebo comparator | Not described Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Mobility Score (NMS)
The primary outcome is to compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility measured with New Mobility Score. New Mobility Score is a validated patient reported outcome measurement 0-9-point score for hip fracture patients, with 9 point equal to a fully independent indoor, outdoor and during shopping walking ability and 0 point, indicating no walking ability. Higher scores indicate a better outcome.
Measured: Measured as the change from baseline (reported as pre-fracture NMS) in the New Mobility Score after 4, 6 and 12 weeks
Secondary outcomes (12)
Hemoglobin
Measured: Measured at baseline, 6 and 12 weeks after intervention.
Red blood cell transfusion requirement
This will be measured by the proportion of patients who receive at least one red blood cell unit and the amounts of units per patient
Measured: Measured on postoperative day (POD) 7 and POD 30
Fatigue, assessed using the Verbal Rating Scale for Fatigue (F-VRS)
Fatigue will be assessed using the Verbal Rating Scale for Fatigue (F-VRS). This scale, ranging from 0 to 4, measures fatigue in hip fracture patients, where 0 indicates no fatigue and 4 represents extreme fatigue.
Measured: Measured at baseline, 4, 6 and 12 weeks after intervention.
Quality of life with EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L )
The EQ-5D-5L questionnaire measures health-related quality of life across five dimensions, with scores ranging from 1 (no problems) to 5 (extreme problems). Higher scores indicate worse outcomes, reflecting greater health issues.
Measured: Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention
EuroQol Visual Analogue Scale (EQ VAS 0-100)
The EQ VAS 0-100 (range) is a visual analogue scale where 0 represents the worst imaginable health state and 100 represents the best. Higher scores on the EQ VAS indicate a better health outcome.
Measured: Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention
Fear of falls measured with, Short Falls Efficacy Scale International (Short-FES-I)
Short Falls Efficacy Scale International (Short-FES-I) measures concern about falling during various activities, with scores ranging from 7 (no concern about falling) to 28 (severe concern about falling). Higher scores indicate greater concern about falling.
Measured: Measured at baseline and at 6 and 12 weeks after intervention.
30 second Sit-to-Stand-Test (STS)
Participants are encouraged to stand and fully sit as many times as possible within 30 seconds, with correct form monitored by the tester. If a participant uses their arms, they score a 0, and only correctly executed stands are counted. This test assesses a wide range of ability levels. Lower score indicates worse outcome.
Measured: Measured at baseline, 6 and 12 weeks
Activity of daily living, asessed with Barthel Index 20
Barthel 20 Index measures a patient's level of independence in daily activities, with scores ranging from 0 (complete dependence) to 20 (complete independence). Higher scores indicate a better outcome, reflecting greater independence.
Measured: Measured as a retrograde baseline and at 6 and 12 weeks after intervention
Pain, assessed using the Verbal Rating Scale for pain
Hip fracture-related pain will be assessed using the Verbal Rating Scale for Pain, which ranges from 0 to 4. A score of 0 indicates no pain, while a score of 4 represents unbearable or the worst imaginable pain
Measured: Measured at baseline and at 6 and 12 weeks after intervention
Days alive and at home up to 30 (DAH30)
The DAH30 is determined using a combination of electronic medical records (obtaining length of stay) and direct participant inquiries at the 6 week follow up
Measured: Measured at 6 weeks after intervention.
Serious adverse event (SAE)
SAE defined following the ICH - GCP guidelines
Measured: Will be assessed up to the 6 weeks follow up
Mortality
The time of death is determined using validated registry-based data, from which survival rates, as well as 30-day and 90-day mortality rates, are calculated.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start9 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion14 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soren Overgaard
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Copenhagen University Hospital at Herlev, Odense University Hospital, Musculoskeletal Statistics Unit, The Parker Institute, Svendborg Hospital
- Responsible party
- Sponsor-investigator, Soren Overgaard, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Nicolas Tekin Jones, MD, Principal investigator, Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898814
- Sponsor's protocol ID
- IronHip Trial
- Other IDs
- 2024-515116-42-00
- Acronym
- IronHip
- Status last verified
- May 2026
- First submitted
- 26 Feb 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.
Publications
Jones NT, Kristensen MT, Christensen R, Alva-Jorgensen JP, Berger AL, Eggertsen MA, Bang Foss N, Henriksen M, Jensen TG, Kidholm K, Lunn TH, Nielsen MS, Palm H, Petersen PB, Stampe H, Viberg B, Overgaard S, Aasbrenn M. The effects of intravenous iron on mobility in older adults following hip fracture surgery: protocol for a multicentre, parallel group, randomised controlled trial - the IronHip trial. BMJ Open. 2026 Jul 13;16(7):e121250. doi: 10.1136/bmjopen-2026-121250.
PubMed 42442814
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06898814
- Acronym / sponsor ID
- IronHip / IronHip Trial
- Conditions
- Hip Fracture, Anemia
- Keywords
- Hip fracture, Anemia, IV Iron, Mobility, Perioperative optimisation, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Soren OvergaardUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg, Copenhagen University Hospital at Herlev, Odense University Hospital, Musculoskeletal Statistics Unit, The Parker Institute, Svendborg Hospital
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 14 Sep 2027 (estimated)
- First posted
- 27 Mar 2025 (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 primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture
The main questions it aims to answer are:
It is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration.
The primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the New Mobility Score.
Participants will:
- Receive either a single dose of intravenous FDI (20 mg/kg body weight) (and saline) or placebo (saline) at 1-5 days after surgery.
This trial will be conducted at three hospitals in Denmark, involving an anticipated 210 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Investigational Medicinal Product | Active comparator | Drug: Ferric Derisomaltose |
| Placebo | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 65 years of age or older
- Acute proximal femur fracture surgery
- A hemoglobin measurement ≤6.5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
- Independent prefracture indoor walking ability, indoor NMS ≥ 2
- Ability to speak and understand Danish
Key exclusion criteria (11 listed)
- Known allergy to intravenous iron
- Residing permanently at a nursing home
- Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
- Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
- Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
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 DerisomaltoseThe active intervention is a single dose of Ferric Derisomaltose, 20mg/kg body weight, diluted in 100 mL isotonic sodium chloride 0.9% | Drug | Active Investigational Medicinal Product |
| Saline (NaCl 0,9 %) (placebo)Single dose of 100 mL isotonic sodium chloride 0.9% | Drug | Placebo |
Primary outcome
New Mobility Score (NMS)
Time frame: Measured as the change from baseline (reported as pre-fracture NMS) in the New Mobility Score after 4, 6 and 12 weeks
The primary outcome is to compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on patients' recovery of functional mobility measured with New Mobility Score. New Mobility Score is a validated patient reported outcome measurement 0-9-point score for hip fracture patients, with 9 point equal to a fully independent indoor, outdoor and during shopping walking ability and 0 point, indicating no walking ability. Higher scores indicate a better outcome.
12 secondary outcomes
Hemoglobin
Time frame: Measured at baseline, 6 and 12 weeks after intervention.
Red blood cell transfusion requirement
Time frame: Measured on postoperative day (POD) 7 and POD 30
Fatigue, assessed using the Verbal Rating Scale for Fatigue (F-VRS)
Time frame: Measured at baseline, 4, 6 and 12 weeks after intervention.
Quality of life with EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L )
Time frame: Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention
EuroQol Visual Analogue Scale (EQ VAS 0-100)
Time frame: Measured as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention
Fear of falls measured with, Short Falls Efficacy Scale International (Short-FES-I)
Time frame: Measured at baseline and at 6 and 12 weeks after intervention.
30 second Sit-to-Stand-Test (STS)
Time frame: Measured at baseline, 6 and 12 weeks
Activity of daily living, asessed with Barthel Index 20
Time frame: Measured as a retrograde baseline and at 6 and 12 weeks after intervention
Pain, assessed using the Verbal Rating Scale for pain
Time frame: Measured at baseline and at 6 and 12 weeks after intervention
Days alive and at home up to 30 (DAH30)
Time frame: Measured at 6 weeks after intervention.
Serious adverse event (SAE)
Time frame: Will be assessed up to the 6 weeks follow up
Mortality
Time frame: 90 days
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 1 Jun 2026.
- Derived from this study: PubMed 42442814Jones NT, Kristensen MT, Christensen R, Alva-Jorgensen JP, Berger AL, Eggertsen MA, Bang Foss N, Henriksen M, Jensen TG, Kidholm K, Lunn TH, Nielsen MS, Palm H, Petersen PB, Stampe H, Viberg B, Overgaard S, Aasbrenn M. The effects of intravenous iron on mobility in older adults following hip fracture surgery: protocol for a multicentre, parallel group, randomised controlled trial - the IronHip trial. BMJ Open. 2026 Jul 13;16(7):e121250. doi: 10.1136/bmjopen-2026-121250.
- Individual participant dataSharing planned: Yes. Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.
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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.
Søren Overgaard, MD, DMSc contact
Nicolas Tekin Jones, MD principal investigator
Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology
3 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 in people with Hip Fracture and Anemia, run by Soren Overgaard at 3 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 6 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: looking for participants now, as of the sponsor's last update on 1 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 3 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 Nicolas Tekin Jones, MD (+4520491890, nicolas.tekin.jones@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Mobility Score (NMS) (time frame: Measured as the change from baseline (reported as pre-fracture NMS) in the New Mobility Score after 4, 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06898814, which also lists 1 linked publication.
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 1 Jun 2026.