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Trial registered on ANZCTR


Registration number
ACTRN12608000463370
Ethics application status
Approved
Date submitted
20/08/2008
Date registered
16/09/2008
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized double blind placebo controlled trial of zoledronate in the treatment of bone erosions in gout
Scientific title
Zoledronate for prevention of erosive gout
Secondary ID [1] 253147 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 3581 0
Condition category
Condition code
Musculoskeletal 3740 3740 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Annual administration of intravenous (iv)zoledronate 5mg over 15 minutes for two years
Intervention code [1] 3296 0
Treatment: Drugs
Comparator / control treatment
Annual administration of iv 0.9% NaCl (Normal Saline) over 15 minutes for two years
Control group
Placebo

Outcomes
Primary outcome [1] 4640 0
Change in total erosion score as determined by computed tomography (CT)scanning of the feet
Timepoint [1] 4640 0
At baseline, 1 year and 2 years
Secondary outcome [1] 7839 0
Change in the volume of three index erosions as determined by CT scanning of the feet
Timepoint [1] 7839 0
At baseline, 1 year and 2 years
Secondary outcome [2] 7840 0
Change in the volume of three index tophi as determined by CT scanning of the feet
Timepoint [2] 7840 0
At baseline, 1 year and 2 years
Secondary outcome [3] 7841 0
Change in plain radiographic damage index score (of the hands and feet, as described by Dalbeth et al 2007)
Timepoint [3] 7841 0
At baseline, 1 year and 2 years
Secondary outcome [4] 7842 0
Change in cartilage turnover markers (CTXII)
Timepoint [4] 7842 0
At baseline, 1 year and 2 years
Secondary outcome [5] 7843 0
Change in pain visual analogue score
Timepoint [5] 7843 0
At baseline, 1 year and 2 years
Secondary outcome [6] 7844 0
Change in subjective functional capacity as measured by the health assessment quesionnaire (HAQ) score
Timepoint [6] 7844 0
At baseline, 1 year and 2 years
Secondary outcome [7] 7845 0
Change in objective functional capacity as measured by dominant hand grip strength
Timepoint [7] 7845 0
At baseline, 1 year and 2 years
Secondary outcome [8] 7846 0
Change in bone mineral densities of the spine, mean total hip and total body using a Prodigy dual energy x-ray absorptiometer
Timepoint [8] 7846 0
At baseline, 1 year and 2 years
Secondary outcome [9] 7847 0
Change in bone turnover markers (PINP and C-telopeptide-I)
Timepoint [9] 7847 0
At baseline, 1 year and 2 years

Eligibility
Key inclusion criteria
A diagnosis of gout, as described by Wallace.
At least one tophus, confirmed by a rheumatologist
On stable therapy for gout (no change in the last 3 months)
Age over 18 years
Able to provide informed consent
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prolonged treatment with potent bisphosphonates in the last two years
Impaired renal function (creatinine clearance <30 ml/minute)
Serum calcium < 2.1mmol/L
Serum 25(OH)D < 15ng/ml
Allergy to bisphosphonate
Pregnancy or breastfeeding
Unstable systemic medical condition

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)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocations will be randomized by the study statistician, using a variable block size schedule, based on computer-generated random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2008
Actual
16/12/2008
Date of last participant enrolment
Anticipated
Actual
2/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 1162 0
New Zealand
State/province [1] 1162 0

Funding & Sponsors
Funding source category [1] 3757 0
University
Name [1] 3757 0
University of Auckland
Country [1] 3757 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Rd,
Grafton,
Private Bag 92019
Auckland
Country
New Zealand
Secondary sponsor category [1] 3372 0
Commercial sector/Industry
Name [1] 3372 0
Novartis
Address [1] 3372 0
Novartis Pharma Services AG
Klybeckstrasse 141
CH-4057 Basel
Country [1] 3372 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5817 0
Northern X Regional Ethics Committee
Ethics committee address [1] 5817 0
650 Gt South Rd,
Penrose
Private Bag 92-522, Wellesley St
Auckland
Ethics committee country [1] 5817 0
New Zealand
Date submitted for ethics approval [1] 5817 0
25/06/2008
Approval date [1] 5817 0
02/07/2008
Ethics approval number [1] 5817 0
NTX/08/06/050

Summary
Brief summary
This is a two-year, double-blind, randomized, placebo-controlled trial of zoledronate for erosive gout. The study will include 100 participants with tophaceous gout; 50 randomly assigned to annual administration of iv zoledronate 5mg, and 50 assigned to annual administration of placebo (0.9%NaCl). Participants will undergo clinical assessment, laboratory testing and radiographic assessment of bone erosion (by CT and plain radiography) at baseline, and after 1 and 2 years.
Zoledronate (5mg) or placebo (0.9% NaCl) will be administered intravenously over 15 minutes during the baseline and year 1 visits. The study duration is 2 years. The primary endpoint will be the change from baseline in total CT erosion score, in the zoledronate group compared to the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28862 0
Prof Nicola Dalbeth
Address 28862 0
Room 502-201D
Bone and Joint Research Group
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton, Auckland 1023
Country 28862 0
New Zealand
Phone 28862 0
+64 (0) 9 3737999 x82568
Fax 28862 0
Email 28862 0
[email protected]
Contact person for public queries
Name 12019 0
Anne Horne
Address 12019 0
Bone Research Group Department of Medicine Auckland University Private Bag 92 019 Auckland 1020
Country 12019 0
New Zealand
Phone 12019 0
+64 9 3078970
Fax 12019 0
+64 9 3737677
Email 12019 0
[email protected]
Contact person for scientific queries
Name 2947 0
Nicola Dalbeth
Address 2947 0
Bone Research Group Department of Medicine Auckland University Private Bag 92 019 Auckland 1020
Country 2947 0
New Zealand
Phone 2947 0
+64 276 977011
Fax 2947 0
+64 9 3737677
Email 2947 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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