Oral bisphosphonate, alendronate, for the treatment of acute Charcot neuroarthropathy in diabetic patients
| ISRCTN | ISRCTN86625608 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86625608 |
| Secondary identifying numbers | 4596 |
- Submission date
- 30/07/2010
- Registration date
- 30/07/2010
- Last edited
- 18/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Edward Jude
Scientific
Scientific
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom
| Edward.Jude@tgh.nhs.uk |
Study information
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Oral bisphosphonate, alendronate, for the treatment of acute Charcot neuroarthropathy in diabetic patients |
| Study acronym | DRN144 |
| Study objectives | 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(s) | MREC approved, ref: 06/Q1407/74 |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network; Subtopic: Both; Disease: Diabetic foot |
| Intervention | Alendronate Follow-up length: 12 months |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Bisphosphonate (alendronate) |
| Primary outcome measure | Reduction in Charcot disease activity |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2008 |
| Completion date | 01/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 78; UK sample size: 78 |
| Key inclusion criteria | 1. Type 1 or type 2 diabetes 2. Aged 18 - 85 years 3. Diabetic neuropathy 4. Active Charcot arthropathy |
| Key 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 |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 01/02/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Tameside General Hospital
Ashton-under-Lyne
OL6 9RW
United Kingdom
OL6 9RW
United Kingdom
Sponsor information
Tameside Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Tameside General Hospital
Fountain Street
Ashton-under-Lyne
OL6 9RW
England
United Kingdom
| Website | http://www.tamesidehospital.nhs.uk/pages/default.asp |
|---|---|
"ROR" |
https://ror.org/04d713p41 |
Funders
Funder type
Charity
Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/04/2017: No publications found, verifying study status with principal investigator.
