Oral bisphosphonate, alendronate, for the treatment of acute Charcot neuroarthropathy in diabetic patients

ISRCTN ISRCTN86625608
DOI https://doi.org/10.1186/ISRCTN86625608
Protocol serial number 4596
Sponsor Tameside Hospital NHS Foundation Trust (UK)
Funder Diabetes UK (UK)
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

Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom

Edward.Jude@tgh.nhs.uk

Study information

Primary study designInterventional
Study designMulticentre randomised interventional treatment trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleOral bisphosphonate, alendronate, for the treatment of acute Charcot neuroarthropathy in diabetic patients
Study acronymDRN144
Study objectivesIncreased 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) studiedTopic: Diabetes Research Network; Subtopic: Both; Disease: Diabetic foot
InterventionAlendronate

Follow-up length: 12 months
Intervention typeDrug
PhasePhase IV
Drug / device / biological / vaccine name(s)Bisphosphonate (alendronate)
Primary outcome measure(s)

Reduction in Charcot disease activity

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/02/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration78
Key inclusion criteria1. Type 1 or type 2 diabetes
2. Aged 18 - 85 years
3. Diabetic neuropathy
4. Active Charcot arthropathy
Key exclusion criteria1. 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 enrolment01/02/2008
Date of final enrolment01/02/2012

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Tameside General Hospital
Ashton-under-Lyne
OL6 9RW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

18/04/2017: No publications found, verifying study status with principal investigator.

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