A randomised double-blind placebo controlled trial of the oral bisphosphonate, Alendronate, plus intravenous pamidronate, in active diabetic Charcot neuroarthropathy (CN). - Use of oral bisphosphonate & I.V. pamidronate in Charcot arthropathy

Phase 1

Conditions: Charcot neuroarthropathyCode: E10.6 Insulin + M14.6Code: E11.6 Insulin + M14.6

Registration Number: EUCTR2006-000900-17-GB

Lead Sponsor: The University of Manchester

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 78

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

1.Peripheral vascular disease (defined as the absence of two or more foot pulses and an ankle brachial index of <0.8)
2.Renal failure (serum creatinine >140 micro mol/l)
3.Foot ulceration or cellulitis or osteomyelitis
4.Previous amputation (midfoot or proximal to mid foot) of either leg

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures