Effect of denosumab on inflammation and bone health in active Charcot foot : A phase II randomised controlled trial
Copyright © 2024 Elsevier Inc. All rights reserved..
AIMS: We aimed to investigate the effect of denosumab on pedal bone health and clinical resolution in active Charcot foot (CN).
METHODS: This multicentre open-label phase 2 randomised controlled trial recruited adults with diabetes mellitus and active CN within 3 months of onset. Participants were randomised to standard care alone, or with denosumab 60 mg subcutaneously. Denosumab was administered at baseline and again at 6 months, unless foot temperature had normalised (i.e. <2 °C compared to contralateral foot). Co-primary outcomes were change in calcaneal Stiffness Index and foot temperature normalisation over 18 months.
RESULTS: Twelve participants per group were analysed; mean age 58 ± 11 years, 83 % male and 92 % had type 2 diabetes. Active CN duration was median 8 (IQR 7-12) weeks. Ninety-two percent were Eichenholtz stage 1 and 96 % involved the midfoot. After 1-month, median decline in Stiffness Index was less in the denosumab verses standard care group (0.5 [IQR -1.0 to 3.9] vs -2.8 [-8.5 to -1.0], p = 0.008). At 18-months, 92 % of the denosumab group attained foot temperature normalisation versus 67 % of the standard care group (p = 0.13).
CONCLUSIONS: Denosumab ameliorated the early decline in calcaneal Stiffness Index associated with active CN. However, no difference in normalisation of foot temperature was observed.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:38 |
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| Enthalten in: |
Journal of diabetes and its complications - 38(2024), 4 vom: 15. Apr., Seite 108718 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lasschuit, Joel Willem Johan [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 01.04.2024 Date Revised 01.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jdiacomp.2024.108718 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369798015 |
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| 100 | 1 | |a Lasschuit, Joel Willem Johan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effect of denosumab on inflammation and bone health in active Charcot foot |b A phase II randomised controlled trial |
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| 500 | |a Date Revised 01.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 Elsevier Inc. All rights reserved. | ||
| 520 | |a AIMS: We aimed to investigate the effect of denosumab on pedal bone health and clinical resolution in active Charcot foot (CN) | ||
| 520 | |a METHODS: This multicentre open-label phase 2 randomised controlled trial recruited adults with diabetes mellitus and active CN within 3 months of onset. Participants were randomised to standard care alone, or with denosumab 60 mg subcutaneously. Denosumab was administered at baseline and again at 6 months, unless foot temperature had normalised (i.e. <2 °C compared to contralateral foot). Co-primary outcomes were change in calcaneal Stiffness Index and foot temperature normalisation over 18 months | ||
| 520 | |a RESULTS: Twelve participants per group were analysed; mean age 58 ± 11 years, 83 % male and 92 % had type 2 diabetes. Active CN duration was median 8 (IQR 7-12) weeks. Ninety-two percent were Eichenholtz stage 1 and 96 % involved the midfoot. After 1-month, median decline in Stiffness Index was less in the denosumab verses standard care group (0.5 [IQR -1.0 to 3.9] vs -2.8 [-8.5 to -1.0], p = 0.008). At 18-months, 92 % of the denosumab group attained foot temperature normalisation versus 67 % of the standard care group (p = 0.13) | ||
| 520 | |a CONCLUSIONS: Denosumab ameliorated the early decline in calcaneal Stiffness Index associated with active CN. However, no difference in normalisation of foot temperature was observed | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Bone health | |
| 650 | 4 | |a Calcaneal quantitative ultrasound | |
| 650 | 4 | |a Charcot foot | |
| 650 | 4 | |a Denosumab | |
| 650 | 4 | |a Diabetes mellitus | |
| 650 | 4 | |a Randomised controlled trial | |
| 650 | 7 | |a Denosumab |2 NLM | |
| 650 | 7 | |a 4EQZ6YO2HI |2 NLM | |
| 700 | 1 | |a Center, Jacqueline Ruth |e verfasserin |4 aut | |
| 700 | 1 | |a Greenfield, Jerry Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Tonks, Katherine Thuy Trang |e verfasserin |4 aut | |
| 700 | 0 | |a Charcot Foot Quantitative Ultrasound and Denosumab Study (CRUSADES) Investigators |e verfasserin |4 aut | |
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