The DENOCHARCOT Trial

Inclusion Criteria:

• Age 18-80 years

• Type 1 or type 2 diabetes (diagnosed diabetes for more than 3 months)

• Diagnosed with acute Charcot foot defined as a unilateral red, swollen and warmfoot, with a difference of skin temperature of more than 2 °C compared with theunaffected foot and with sign of Charcot on either x-rays of the foot, MRI, bonescintigram or PET/CT.

• Peripheral neuropathy: Previously diagnosed and/or biothesiometri: > 25 V or lack ofsensation of 10 grams monofilament on 1. toe at the acute Charcot foot.

Exclusion Criteria:

• 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/orradiologically 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 hypersensitivityto Denosumab • History of osteonecrosis of the jaw.

• Poor oral hygiene, which is defined as within 3 months of a tooth extraction, dentalimplants 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 asbisphosphonates, Forsteo®, calcitonin, Protelos®, selective estrogen receptormodulators, glucocorticoids and sex hormones)

• Active or chronic liver disease *Chronic liver disease is defined as clinicalhistory of decompensated chronic liver disease (ascites, encephalopathy or varicealbleeding) *Acute Liver disease is defined as an INR of > 1.5 (in the absence of theuse 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 administeredglucocorticoids

• Abuse of alcohol or drugs, or presence of any condition that in the Investigatorsopinion may lead to poor adherence to study protocol

• Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptivemethods. 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 couldinterfere with the outcome of the treatment of the acute Charcot foot.

• Cancer, or any clinically significant disease or disorder, except for conditionsassociated to the diabetes, which in the Investigator's opinion could interfere withthe results of the trial