An Open Label study of the drug denosumab in acute Diabetes Charcot’s Neuroarthropathy.
A Two Part Phase II Open Label Study on the effects of Denosumab in modifying disease activity in patients with Diabetes Mellitus and Charcot Neuropathic Osteoarthropathy.
South Western Sydney Local Health District
36 participants
Sep 25, 2014
Interventional
Conditions
Summary
We aim to explore if the drug ‘denosumab’ is effective at reducing bone loss in the feet/foot in participants with Diabetes Mellitus and Charcot Foot. Bone loss or Osteoponia as it is referred to medically is a recognised feature of Charcot foot. If the bone loss process can be prevented then this may stop the Charcot process in a much quicker time frame.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The study aims to seek evidence that RANKL blockade using the drug Denosumab can modify disease activity in Charcot Neuropathic Osteoarthropathy. The dose of Denosumab that will be administered is the same as current TGA approved for the treatment of osteoporosis in postmenopausal women and androgen deprived men. The dose is 60 mg administered subcutaneously in a single, one off injection. Follow up will last for 12 months.
Locations(3)
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ACTRN12614000326695