RecruitingPhase 2ACTRN12614000326695

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.


Sponsor

South Western Sydney Local Health District

Enrollment

36 participants

Start Date

Sep 25, 2014

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether the drug denosumab can reduce bone loss in the feet of people with diabetes who have Charcot foot — a serious condition where bones in the foot weaken and can fracture or collapse. Researchers hope that by stopping bone loss, the Charcot process might resolve more quickly. You may be eligible if: - You are between 18 and 85 years old - You have Type 1 or Type 2 diabetes - You have diabetic peripheral neuropathy (nerve damage in your feet) - You have been diagnosed with acute Charcot foot You may NOT be eligible if: - You are pregnant, breastfeeding, or a woman of childbearing age not using contraception - You have peripheral vascular disease (poor blood flow to the legs/feet) without successful treatment - You have a serious foot ulcer, infection, or bone infection (osteomyelitis) in the affected foot - You have low calcium or vitamin D deficiency - You have significant kidney, liver, or heart failure - You have inflammatory arthritis or bowel disease - You have had a tooth extraction, dental implant, or jaw surgery within the last 3–6 months, or have multiple dental cavities - You have received denosumab in the past 12 months Talk to your doctor about whether this trial might be right for you.

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

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)

Liverpool Hospital - Liverpool

NSW,QLD,VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

NSW,QLD,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,VIC, Australia

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ACTRN12614000326695


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