IRONCARE: Iron Treatment in Older Patients With Hip Fractures
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).
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Ole Vincent Ancker, MD
- 電話番号：+4551322385
- メール：ole.ancker@rm.dk
研究連絡先のバックアップ
- 名前：Merete Gregersen, ph.d.
- メール：meregreg@rm.dk
研究場所
-
-
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Aarhus N、デンマーク、8200
- Aarhus Univeristy Hospital
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コンタクト：
- Ole Vincent Ancker, MD
- 電話番号：+4551352385
- メール：ole.ancker@rm.dk
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Herning、デンマーク、7400
- Regional Hospital Gødstrup
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コンタクト：
- Ole Vincent Ancker, MD
- 電話番号：+4551352385
- メール：ole.ancker@rm.dk
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Horsens、デンマーク、8700
- Regional Hospital Horsens
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コンタクト：
- Ole Vincent Ancker, MD
- 電話番号：+4551352385
- メール：ole.ancker@rm.dk
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Randers、デンマーク、8930
- Regional Hospital Randers
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コンタクト：
- Ole Vincent Ancker, MD
- 電話番号：+4551352385
- メール：ole.ancker@rm.dk
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Viborg、デンマーク、8800
- Regional Hospital Viborg
-
コンタクト：
- Ole Vincent Ancker, MD
- 電話番号：+4551352385
- メール：ole.ancker@rm.dk
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-
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：IV Iron
Intravenous iron once and placebo tablets on alternate days for 90 days
|
Intravenous Ferric Derisomaltose shortly after surgery and placebo tablets on alternate days for 90 days
Placebo tablets on alternate days for 90 days
|
|
アクティブコンパレータ：Oral Iron
Intravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days
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Oral iron sulfate on alternate days for 90 days and IV placebo once shortly after surgery
100 ml Sodium Chloride (NaCl)
|
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プラセボコンパレーター：Placebo
Intravenous sodium chloride once and placebo tablets on alternate days for 90 days
|
Placebo tablets on alternate days for 90 days
100 ml Sodium Chloride (NaCl)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fatigue
時間枠：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.
|
Baseline and days 30 and 90 after discharge
|
|
Hemoglobin increment
時間枠：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
|
Baseline and days 30 and 90 after discharge
|
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Safety profile
時間枠：Days 15, 30, 45 and 90 after discharge
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Measured as the prevalence and severity of adverse events associated with iron treatment
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Days 15, 30, 45 and 90 after discharge
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical function - NMS
時間枠：Baseline and days 30 and 90 after discharge
|
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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Physical function - handgrip strength
時間枠：Baseline and days 30 and 90 after discharge.
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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.
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Baseline and days 30 and 90 after discharge.
|
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Physical function - 30 second sit-to-stand-test
時間枠：Baseline and days 30 and 90 after discharge.
|
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
時間枠：Days 30 and 90 after discharge
|
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).
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Days 30 and 90 after discharge
|
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Quality of life
時間枠：Baseline and 90 days after discharge
|
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.
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Baseline and 90 days after discharge
|
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Cognitive impairment
時間枠：Baseline and days 30 and 90 after discharge
|
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
|
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Biochemical iron status - transferrin
時間枠：Baseline and on days 30 and 90 after discharge
|
p-transferrin (μmol/L) measured by a venous blood sample.
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Baseline and on days 30 and 90 after discharge
|
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Biochemical iron status - ferritin
時間枠：Baseline and on days 30 and 90 after discharge
|
p-ferritin (μg/L) measured by a venous blood sample
|
Baseline and on days 30 and 90 after discharge
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRONCARE-2026
- 2026-526949-94-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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