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

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:
• •1. Infection
• •2. Foot ulceration
• •3. Hypocalcemia
• •4. Creatinine clearance less than 30 mL/min or on dialysis
• •5. 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)