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Trial registered on ANZCTR


Registration number
ACTRN12611000065998
Ethics application status
Approved
Date submitted
28/12/2010
Date registered
19/01/2011
Date last updated
19/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of zolendronic acid on the clinical resolution of acute midfoot Charcot foot
Scientific title
The effect of zolendronic acid on the clinical resolution of acute midfoot Charcot foot
Secondary ID [1] 253333 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Charcot neuroarthropathy in patients with diabetes mellitus 258872 0
Condition category
Condition code
Musculoskeletal 259009 259009 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 259123 259123 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with acute Charcot foot receive either 3 intravenous infusions of placebo (normal saline) or 4mg of zolendronic acid (bisphosphonate) in 4 week intervals
Intervention code [1] 257785 0
Treatment: Drugs
Comparator / control treatment
Placebo (normal saline)
Control group
Placebo

Outcomes
Primary outcome [1] 259866 0
Total immobilisation time in cast
Timepoint [1] 259866 0
6 months and 1 year
Secondary outcome [1] 268744 0
Number of any surgical procedures of the affected foot during the first year of follow-up. Data is collected prospectively from patient records.
Timepoint [1] 268744 0
1 year

Eligibility
Key inclusion criteria
Patients with acute unilateral Charcot foot and type I or type II diabetes mellitus
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serum creatine >400 umol/l

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3113 0
Finland
State/province [1] 3113 0

Funding & Sponsors
Funding source category [1] 258256 0
Hospital
Name [1] 258256 0
Pirkanmaa Hospital District
Address [1] 258256 0
Teiskontie 35
33521 Tampere
Finland
Country [1] 258256 0
Finland
Primary sponsor type
Hospital
Name
Pirkanmaa Hospital District
Address
Teiskontie 35
33521 Tampere
Finland
Country
Finland
Secondary sponsor category [1] 257421 0
University
Name [1] 257421 0
Medical School, University of Tampere
Address [1] 257421 0
Tesikontie
33521 Tampere
Finland
Country [1] 257421 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260231 0
Pirkanmaa Hospital Districts Ethics Commitee
Ethics committee address [1] 260231 0
Teiskontie 35
33521 Tampere
Finland
Ethics committee country [1] 260231 0
Finland
Date submitted for ethics approval [1] 260231 0
10/11/2001
Approval date [1] 260231 0
11/12/2001
Ethics approval number [1] 260231 0
R01165M

Summary
Brief summary
Diabetic Charcot foot is a rare but devastating foot complication of diabetes mellitus. The resolution of the acute form of Charcot foot needs immobilisation in a cast and total non-weight bearing for at least 12 to 16 weeks. Increased osteoclastic activity is thought to be one of the main pathological feature of the acute Charcot foot. That is why bisphosphonates are widely used in the treatment of acute Charcot process. There are some preliminary studies about the effect of bisphosphonates on the resolution of acute Charcot foot. In this study we investigated the effect of zoledronic acid on the clinical resolution of acute Charcot foot.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32043 0
Address 32043 0
Country 32043 0
Phone 32043 0
Fax 32043 0
Email 32043 0
Contact person for public queries
Name 15290 0
Toni-Karri Pakarinen
Address 15290 0
Dept. of Orthopaedics and Traumatology
Teiskontie 35
33521 Tampere
Finland
Country 15290 0
Finland
Phone 15290 0
+358-3-31165009
Fax 15290 0
Email 15290 0
toni-karri.pakarinen@pshp.fi
Contact person for scientific queries
Name 6218 0
Toni-Karri Pakarinen
Address 6218 0
Dept. of Orthopaedics and Traumatology
Teiskontie 35
33521 Tampere
Finland
Country 6218 0
Finland
Phone 6218 0
+358-3-31165009
Fax 6218 0
Email 6218 0
toni-karri.pakarinen@pshp.fi

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary