The effects of intravenous iron on mobility in elderly patients following hip fracture surgery: a multicentre, parallel group, randomised, controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstaden

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

2 Jun 2025 → ongoing

Decision date (initial)

2025-02-09

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

PHARMACOSMOS A/S · Independent research fund Denmark

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

The primary objective 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 as the change from baseline in the New Mobility Score (NMS) after 6 weeks

Secondary objectives 11

1. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on anaemia measured post-operatively week 6
2. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on the amount of received red blood cell transfusion to week 6
3. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on patient fatigue, measured at week 6
4. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on quality of life measured with the EQ-5D-5L and EQ VAS
5. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on fear of falls will be measured at week 6
6. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on 30 second Sit-to-Stand-Test measured as the change from baseline after 6 weeks
7. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on Activities of Daily Living (ADL) measured at week 6
8. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on Pain will be measured at week 6
9. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on Health Resource Use
10. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on Serious adverse events (SAE) measured at week 6
11. To compare the effect of a single dose of FDI (20 mg/kg body weight) relative to placebo on Mortality at up to 90 days

Conditions and MedDRA coding

Hip fracture

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. - 65 years of age or older
2. - Acute proximal femur fracture surgery
3. - A haemoglobin measurement ≤6,5 mmol/L (10.5 g/dL) on day 1 to 5 postoperatively
4. - Independent prefracture indoor walking ability, indoor NMS ≥ 2
5. - Ability to speak and understand Danish
6. - Able to provide informed consent on their own behalf

Exclusion criteria 11

1. - No known allergy to intravenous iron
2. - Residing permanently at a nursing home
3. - Haematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies
4. - Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis
5. - Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)
6. - Plasma sodium levels below 125 or above 150 mmol/L on the day of inclusion
7. - Renal replacement therapy
8. - Severe dementia assessed by physician
9. - Recent intravenous iron injection, 4 weeks prior to surgery
10. - Patient declared terminal ill
11. - Pathologic Fracture

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Participants will report their pre-fracture NMS at baseline. NMS will be assessed by phone at week 4 post-intervention and in-person at weeks 6 and 12. Mobility recovery from pre-fracture will be analyzed using repeated measures mixed linear models, with the primary endpoint being NMS after 6 weeks, estimated by least squares means difference

Secondary endpoints 11

1. 1. Haemoglobin Blood test will be obtained, and haemoglobin analysed at baseline and following the 6- and 12-week patient visit.
2. 2. 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 on postoperative day (POD) 7 and POD 30 attained from electronic patient records.
3. 3. Fatigue will be measured with ‘Verbal rating scale – Fatigue’ from 0, 4 and at 6 and 12 weeks after intervention
4. 4. Quality of life: This will be measured by dedicated staff using the questionnaire EQ-5D-5L and EQ VAS 0-100, on inclusion as a retrograde baseline the weeks prior to admission and at 6 and 12 weeks after intervention.
5. 5. Fear of falls: Short Falls efficacy scale International (Short-FES-I) for assessment of concern for falling during different activities measured at baseline and at 6 and 12 weeks after intervention
6. 6. 30 second Sit-to-Stand-Test (STS) The test uses a chair placed against a wall, with the participant seated in the middle and arms crossed at the chest. Participants are encouraged to stand and fully sit as many times as possible within 30 seconds, with correct form monitored by the tester. Measured at baseline, 6 and 12 weeks. Measured at baseline, 6 and 12 weeks. Measured at baseline, 6 and 12 weeks. Measured at baseline and at 6 and 12 weeks.
7. 6. Activity of daily living: Barthel Index 20 Barthel measured at baseline and at 6 and 12 weeks after intervention.
8. 7. Pain: Hip fracture-related pain during activity will be evaluated with the verbal rating scale, 0-4 points, at baseline and at 6 and 12 weeks after intervention.
9. 8. Days alive and at home up to 30 days, assessed at 6 week follow up
10. 9. Serious adverse event: SAE defined following the ICH – GCP guidelines. Will be assessed at the 6 weeks follow up.
11. 10. Mortality: 90 days following enrolment it is obtained if patients are alive from patient electronic medical records and from this survival, 30 and 90 mortality is calculated

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Bispebjerg Bakke 23

City

Copenhagen Nv

Postcode

2400

Country

Denmark

Scientific contact point

Organisation

Region Hovedstaden

Contact name

Søren Overgaard

Public contact point

Organisation

Region Hovedstaden

Contact name

Søren Overgaard

Third parties 1

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications