Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy

Inclusion criteria

• Men or women > 30 years old
• Subject is able and willing to comply with study procedures, and is able to give signed and dated consent
• Subject meets criteria for diagnosis of Diabetes Mellitus Type 1 or 2, active Charcot neuroarthropathy, and peripheral neuropathy
• Subjects with serum calcium or albumin-adjusted serum calcium ≥2.0 mmol/L (8.0mg/dL)

Exclusion criteria

• Unable to provide signed and dated consent.
• Charcot neuroarthropathy of the ipsilateral lower extremity, diagnosed over 1 month prior.
• Prior foot or ankle surgery of the ipsilateral lower extremity.
• Prior amputation at any level of either lower extremity.
• Prior foot or ankle fracture of the ipsilateral lower extremity unrelated to the current acute CN episode.
• Currently has any of the following:

• Infection
• Foot ulceration
• Hypocalcemia
• Creatinine clearance less than 30 mL/min or on dialysis
• Pre-existing disturbance of mineral metabolism (e.g., hypoparathyroidism unstable on therapy, thyroid or parathyroid surgery, vitamin D deficiency, malabsorption syndromes, excision of small intestine, history of diseases affecting bone metabolism) that has not been effectively corrected or treated.
• Have undergone revascularization procedures of the lower extremities.
• Female subjects who are pregnant or planning to breastfeed should not participate in this study.
• Determined to have poor oral hygiene after dental screening or are at increased risk for developing osteonecrosis of the jaw.
• History of osteonecrosis of the jaw.
• History of tooth extraction or other dental surgery within the prior 6 months.
• Invasive dental work planned in the next 2 years.
• Have a known hypersensitivity to Prolia.
• Known use of a bone active medication within the 6 months prior to enrollment.
• Liver disease, defined as AST > 2.0x ULN, ALT > 2.0x ULN, TBL > 1.5x ULN.
• Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)