Charcot neuroarthropathy Code: E10.6 Insulin + M14.6 Code: E11.6 Insulin + M14.6
Conditions
Interventions
Trade Name: Fosamax
Product Name: Fosamax® Once Weekly 70mg
Product Code: any
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
T
Sponsors
The University of Manchester
Central Manchester and Manchester Children's University NHS trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 1 or type 2 diabetes 2. Age 18-85 years 3. Diabetic neuropathy 4. Active Charcot Neuroarthopathy 5. Patients in whom the study drug (Alendronate) would be contraindicated: such as patients with abnormalities of the oesophagus (e.g. stricture, achalasia), gastric or duodenal ulcers, calcium disorders, pregnancy and breast-feeding. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Peripheral vascular disease (defined as the absence of two or more foot pulses and an ankle brachial index of 140 micro mol/l) 3. Foot ulceration or cellulitis or osteomyelitis 4. Previous amputation (midfoot or proximal to mid foot) of either leg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this study we aim to confirm the hypothesis that bisphosphonates (drugs currently used drugs used to prevent and treat osteoporosis), can modify disease activity (as assessed by skin temperature over the affected part of the foot) in Charcot neuroarthropathy and also influence the underlying pathogenesis of the condition by measurement of bone turnover markers.;Secondary Objective: To determine whether the treatment will be effective in modifying the disease process a standard x-ray of the involved feet will be taken at the start of the study and at the end of 12 months. In addition, disease activity using a bone scan will be carried out, after 1 month and again at 3 months, to examine whether the bisphosphonates have had any effect on the inflammatory process within the bones. ;Primary end point(s): A reduction in foot temperature difference between the affected and contralateral limb | — |
Countries
United Kingdom
Outcome results
None listed