Contact information
Type
Scientific
Primary contact
Dr Edward Jude
ORCID ID
Contact details
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom
-
Edward.Jude@tgh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4596
Study information
Scientific title
Oral bisphosphonate, alendronate, for the treatment of acute Charcot neuroarthropathy in diabetic patients
Acronym
DRN144
Study hypothesis
Increased osteoclastic activity, resulting in osteopaenia, is a recognised feature of the pathogenesis of Charcot neuroarthropathy (CN); therapeutic agents which inhibit osteoclastic bone resorption should be efficacious in arresting the Charcot disease process. Our previously published study of the bisphosphonate pamidronate in this condition demonstrated improvement in symptoms and markers of bone turnover but no influence on disease activity. This necessitates the need for a larger randomised trial and with the availability of more potent oral bisphosphonates we propose to use the bisphosphonate alendronate in a randomised double-blind placebo-controlled trial. In active diabetic CN, we aim to confirm the hypothesis that bisphosphonates can modify disease activity and also influence the underlying pathogenesis of the condition.
Ethics approval
MREC approved, ref: 06/Q1407/74
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Diabetes Research Network; Subtopic: Both; Disease: Diabetic foot
Intervention
Alendronate
Follow-up length: 12 months
Intervention type
Drug
Phase
Phase IV
Drug names
Bisphosphonate (alendronate)
Primary outcome measure
Reduction in Charcot disease activity
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2008
Overall trial end date
01/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Type 1 or type 2 diabetes
2. Aged 18 - 85 years
3. Diabetic neuropathy
4. Active Charcot arthropathy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 78; UK sample size: 78
Participant exclusion criteria
1. Peripheral vascular disease
2. Renal failure
3. Foot ulceration or celluitis or osteomyelitis
4. Previous amputation (more than midfoot)
5. Contraindication to study drug
6. Oesophageal or gastric problems (achalasia, ulcers)
7. Pregnancy
8. Breastfeeding
9. Risk factors for jaw osteonecrosis
Recruitment start date
01/02/2008
Recruitment end date
01/02/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Tameside General Hospital
Ashton-under-Lyne
OL6 9RW
United Kingdom
Sponsor information
Organisation
Tameside Hospital NHS Foundation Trust (UK)
Sponsor details
Tameside General Hospital
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Diabetes UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list