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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526949-94-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Region MidtJylland Denmark | OTHER |
| Viborg Regional Hospital | OTHER |
| Gødstrup Hospital | OTHER |
| Aarhus University Hospital |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Iron | Active Comparator | Intravenous iron once and placebo tablets on alternate days for 90 days |
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| Oral Iron | Active Comparator | Intravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days |
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| Placebo | Placebo Comparator | Intravenous sodium chloride once and placebo tablets on alternate days for 90 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Derisomaltose | Drug | Intravenous Ferric Derisomaltose shortly after surgery and placebo tablets on alternate days for 90 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline and days 30 and 90 after discharge |
| Safety profile | Measured as the prevalence and severity of adverse events associated with iron treatment | Days 15, 30, 45 and 90 after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and days 30 and 90 after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ole Vincent Ancker, MD | Contact | +4551322385 | ole.ancker@rm.dk | |
| Merete Gregersen, ph.d. | Contact | meregreg@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Univeristy Hospital | Aarhus N | 8200 | Denmark |
Upon relevant request
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D000740 | Anemia |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| C000718030 | ferric derisomaltose |
| D007501 | Iron |
| C020748 | ferrous sulfate |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| OTHER |
| Randers Regional Hospital | OTHER |
| Regionshospitalet Horsens | OTHER |
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| Oral Iron (Ferrous sulphate) | Drug | Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery |
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| Placebo IV | Drug | 100 ml Sodium Chloride (NaCl) |
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| Placebo Tablets | Drug | Placebo tablets on alternate days for 90 days |
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| 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. | 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. | 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). | 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. | 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. | Baseline and 90 days after discharge |
| Biochemical iron status - transferrin | p-transferrin (μmol/L) measured by a venous blood sample. | Baseline and on days 30 and 90 after discharge |
| Biochemical iron status - ferritin | p-ferritin (μg/L) measured by a venous blood sample | Baseline and on days 30 and 90 after discharge |
| Regional Hospital Gødstrup | Herning | 7400 | Denmark |
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| Regional Hospital Horsens | Horsens | 8700 | Denmark |
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| Regional Hospital Randers | Randers | 8930 | Denmark |
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| Regional Hospital Viborg | Viborg | 8800 | Denmark |
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| D007869 |
| Leg Injuries |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |