Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/07/2010
Date assigned
30/07/2010
Last edited
28/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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 measures

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

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

Fountain Street
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

http://www.tamesidehospital.nhs.uk/pages/default.asp

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes