The DENOCHARCOT Trial

Summary

The aim of the present trial is to assess the efficacy of treatment of acute Charcot foot in diabetes patients with Prolia® on clinical relevant Outcomes in a randomized, double blind, placebo-controlled trial.

Timeline

Start

2020-11-01

Primary completion

2025-10-01

Completion

2026-10-01

Publications

• Background Jeffcoate WJ. Charcot foot syndrome. Diabet Med. 2015 Jun;32(6):760-70. doi: 10.1111/dme.12754. Epub 2015 Apr 15.
• Background Christensen TM, Gade-Rasmussen B, Pedersen LW, Hommel E, Holstein PE, Svendsen OL. Duration of off-loading and recurrence rate in Charcot osteo-arthropathy treated with less restrictive regimen with removable walker. J Diabetes Complications. 2012 Sep-Oct;26(5):430-4. doi: 10.1016/j.jdiacomp.2012.05.006. Epub 2012 Jun 12.
• Background Pitocco D, Ruotolo V, Caputo S, Mancini L, Collina CM, Manto A, Caradonna P, Ghirlanda G. Six-month treatment with alendronate in acute Charcot neuroarthropathy: a randomized controlled trial. Diabetes Care. 2005 May;28(5):1214-5. doi: 10.2337/diacare.28.5.1214. No abstract available.
• Background Anderson JJ, Woelffer KE, Holtzman JJ, Jacobs AM. Bisphosphonates for the treatment of Charcot neuroarthropathy. J Foot Ankle Surg. 2004 Sep-Oct;43(5):285-9. doi: 10.1053/j.jfas.2004.07.005.
• Background Jude EB, Selby PL, Burgess J, Lilleystone P, Mawer EB, Page SR, Donohoe M, Foster AV, Edmonds ME, Boulton AJ. Bisphosphonates in the treatment of Charcot neuroarthropathy: a double-blind randomised controlled trial. Diabetologia. 2001 Nov;44(11):2032-7. doi: 10.1007/s001250100008.
• Background Bem R, Jirkovska A, Fejfarova V, Skibova J, Jude EB. Intranasal calcitonin in the treatment of acute Charcot neuroosteoarthropathy: a randomized controlled trial. Diabetes Care. 2006 Jun;29(6):1392-4. doi: 10.2337/dc06-0376. No abstract available.
• Background Pakarinen TK, Laine HJ, Maenpaa H, Mattila P, Lahtela J. The effect of zoledronic acid on the clinical resolution of Charcot neuroarthropathy: a pilot randomized controlled trial. Diabetes Care. 2011 Jul;34(7):1514-6. doi: 10.2337/dc11-0396. Epub 2011 May 18.
• Background Petrova NL, Dew TK, Musto RL, Sherwood RA, Bates M, Moniz CF, Edmonds ME. Inflammatory and bone turnover markers in a cross-sectional and prospective study of acute Charcot osteoarthropathy. Diabet Med. 2015 Feb;32(2):267-73. doi: 10.1111/dme.12590. Epub 2014 Oct 17.
• Background Jansen RB, Christensen TM, Bulow J, Rordam L, Jorgensen NR, Svendsen OL. Markers of Local Inflammation and Bone Resorption in the Acute Diabetic Charcot Foot. J Diabetes Res. 2018 Aug 2;2018:5647981. doi: 10.1155/2018/5647981. eCollection 2018.
• Background Busch-Westbroek TE, Delpeut K, Balm R, Bus SA, Schepers T, Peters EJ, Smithuis FF, Maas M, Nieuwdorp M. Effect of Single Dose of RANKL Antibody Treatment on Acute Charcot Neuro-osteoarthropathy of the Foot. Diabetes Care. 2018 Mar;41(3):e21-e22. doi: 10.2337/dc17-1517. Epub 2017 Dec 22. No abstract available.
• Background Tsourdi E, Langdahl B, Cohen-Solal M, Aubry-Rozier B, Eriksen EF, Guanabens N, Obermayer-Pietsch B, Ralston SH, Eastell R, Zillikens MC. Discontinuation of Denosumab therapy for osteoporosis: A systematic review and position statement by ECTS. Bone. 2017 Dec;105:11-17. doi: 10.1016/j.bone.2017.08.003. Epub 2017 Aug 5.

Drugs

Indications