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

Launched by WESTERN UNIVERSITY OF HEALTH SCIENCES · May 30, 2017

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• 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:
• • 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)