The DENOCHARCOT Trial

Exclusion Criteria24

• Duration of the acute Charcot foot for more than 3 months (at the screening visit).
• Existing foot ulcer on the affected foot
• Previous acute or chronic Charcot of the affected foot
• Planned surgery on the acute Charcot foot
• Infection (cellulitis or osteomyelitis) of the affected foot (clinically and/or radiologically proven)
• Previous midfoot or proximal to mid foot amputation of the affected foot
• Hypocalcemia (Serum Calcium <2.1 mmol/L or Calcium ion < 1.12 mmol/L)
• Vitamin D deficiency (Serum 25-hydroxyvitamin D < 50 nmol/L)
• Renal failure (serum creatinine >200 mmol/L or eGFR < 30 ml/min).
• Treatment with Denosumab within the last 12 months. • Have a known hypersensitivity to Denosumab • History of osteonecrosis of the jaw.
• Poor oral hygiene, which is defined as within 3 months of a tooth extraction, dental implants or mandibular surgery
• Planned mandibular surgery or dental implants within the next 12 months.
• Prior non-traumatic vertebral fracture
• Treatment with medication known to affect bones within the last 12 months (such as bisphosphonates, Forsteo®, calcitonin, Protelos®, selective estrogen receptor modulators, glucocorticoids and sex hormones)
• Active or chronic liver disease *Chronic liver disease is defined as clinical history of decompensated chronic liver disease (ascites, encephalopathy or variceal bleeding) *Acute Liver disease is defined as an INR of > 1.5 (in the absence of the use of Warfarin) and AST and ALT > 2 x ULN
• History of inflammatory arthropathies (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, autoimmune arthropathy)
• Pre-existing medical condition judged to preclude safe participation in the study
• Current treatment with cytotoxic drugs or with systemically administered glucocorticoids
• Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol
• Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods. The following contraceptive products are considered to be safe: Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections).
• Likely inability to comply with the visits because of planned activity
• Use of any investigational product with the last month.
• Use of any drug or any other reason which in the Investigator's opinion could interfere with the outcome of the treatment of the acute Charcot foot.
• Cancer, or any clinically significant disease or disorder, except for conditions associated to the diabetes, which in the Investigator's opinion could interfere with the results of the trial