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

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 7

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group, receiving medication	Denosumab	Subjects in this group will be receiving medication (denosumab)

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	1 year	Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]

Secondary Outcome Measures

Name	Time	Method
Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months.	6 months	Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.