An Open Label study of the drug denosumab in acute Diabetes Charcot’s Neuroarthropathy.

A Two Part Phase II Open Label Study on the effects of Denosumab in modifying disease activity in patients with Diabetes Mellitus and Charcot Neuropathic Osteoarthropathy.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000326695

Acronym

2 POD-C

Enrollment

Registered

2014-03-26

Start date

2014-09-25

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to explore if the drug ‘denosumab’ is effective at reducing bone loss in the feet/foot in participants with Diabetes Mellitus and Charcot Foot. Bone loss or Osteoponia as it is referred to medically is a recognised feature of Charcot foot. If the bone loss process can be prevented then this may stop the Charcot process in a much quicker time frame.

Interventions

The study aims to seek evidence that RANKL blockade using the drug Denosumab can modify disease activity in Charcot Neuropathic Osteoarthropathy. The dose of Denosumab that will be administered is the same as current TGA approved for the treatment of osteoporosis in postmenopausal women and androgen deprived men. The dose is 60 mg administered subcutaneously in a single, one off injection. Follow up will last for 12 months.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

Type 1 or Type 2 diabetes Diabetic peripheral neuropathy

Exclusion criteria

1. Pregnant women or women of child-bearing age not using contraception 2. Women who are breastfeeding 3. Peripheral vascular disease – confirmed by clinical history PLUS absence of two or more foot pulses or an ankle brachial index of <0.8 (see below) NB: Patients with known PVD and who have undergone successful revascularization as determined by clinical history PLUS palpable pulses PLUS bi- or tri -phasic Doppler wave forms are NOT excluded. 4. Foot ulceration > Texas classification 1A NB: A foot ulcer with Texas classification grade 1A has met inclusion criteria in previous studies of acute CN. 5. Cellulitis and/or osteomyelitis of the affected foot (clinically and/or radiologically proven) 6. Previous midfoot or proximal to mid foot amputation 7. Hypocalcaemia (Serum Calcium <2.1 mmol/L) 8. Vitamin D deficiency (Serum 25-hydroxyvitamin D <30 nmol/L) 9. History of hypoparathyroidism or pending thyroid or parathyroid surgery 10. Poor oral hygiene, which is defined as: *Within 3 months of a tooth extraction, dental implants or mandibular surgery *Within 6 months of planned tooth extraction, dental implants or mandibular surgery *Presence of multiple (more than 3) dental caries NB: Previous dental clearance and the use of a dental plate(s) are NOT contra-indication for enrollment NB: This is because osteonecrosis of the jaw (ONJ) has been reported in patients treated with Denosumab. 11. Renal failure (serum creatinine >200 mmol/L or eGFR< 30 ml/min). 12. 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 2xULN 13. History of decompensated congestive heart failure 14. History of inflammatory arthopathies (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, autoimmune arthopathy) 15. History of inflammatory bowel disease (Crohn’s disease, Ulcerative Colits, other inflammatory colitis) 16. Any history of treatment with Denosumab within the last 12 months.

Outcome results