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Trial registered on ANZCTR
Registration number
ACTRN12609000399291
Ethics application status
Approved
Date submitted
13/05/2009
Date registered
2/06/2009
Date last updated
14/01/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised controlled trial on the effect of zolendronic acid versus placebo on the amount of knee pain in patients with bone marrow oedema-associated knee pain.
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Scientific title
Patients with bone marrow oedema-associated knee pain, randomised to zolendronic acid or placebo, assessed by the amount of knee pain after three and twelve months.
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Secondary ID [1]
288320
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Nil
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Universal Trial Number (UTN)
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Trial acronym
ZAP1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee Pain
4883
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Condition category
Condition code
Musculoskeletal
237256
237256
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0
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Once-off intravenous infusion of 5mg zolendronic acid
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Intervention code [1]
236691
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Treatment: Drugs
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Comparator / control treatment
Once-off intravenous infusion of 5mg saline
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Magnetic resonance imaging assesment of bone marrow lesions
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Assessment method [1]
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Timepoint [1]
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6 months following the commencement of treatment
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Secondary outcome [1]
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Knee pain as measured by visual analogue score and magnetic resonance imaging
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Assessment method [1]
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Timepoint [1]
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6 months following the commencement of treatment
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Secondary outcome [2]
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Knee Function, using a questionnaire: Knee injury and Osteoarthritis Outcome Score (KOOS).
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Assessment method [2]
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Timepoint [2]
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3, 6 and 12 months following the commencement of treatment
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Secondary outcome [3]
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Safety, using interview.
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Assessment method [3]
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Timepoint [3]
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Each visit: 3, 6 and 12 months following the commencement of treatment
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Eligibility
Key inclusion criteria
Knee Pain with bone marrow oedema on magnetic resonance imaging (MRI).
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Minimum age
50
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Any prior use of bisphosphonate preparations, except according to the washout schedule:
2 years (if use >48 weeks)
1 year (if used >8 weeks but <48 weeks)
6 months (if used >2 weeks but <8 weeks)
2 months (if used <2 weeks)
Any intravenous bisphosphonate within the prior 2 years,
History of iritis or uveitis, except due to trauma, and resolved for >2 years prior to study
Serum calcium >2.75 mmol/L (11.0 mg/dL) or <2.00 mmol/L (8.0 mg/dL)
Serum 25-hydroxyvitamin D concentrations <15 ng/L
Use of any investigational drug(s) and/or devices within 30 days prior to randomization
creatinine clearance < 35 ml/min
Metastatic cancer or cancer diagnosed less than 2 years ago where treatment is still ongoing
A dental exam with appropriate preventative dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, corticosteroids, poor hygiene)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be recruited by newspaper advertising.
Subjects that meet the inclusion criteria and did not meet the exclusion criteria were given an MRI.
Subject with bone marrow oedema visualised on MRI are then randomised to treatment or placebo. Allocation was determined from computer generated random numbers. Staff members not involved in assessing trial patients or performing infusions will generate the random sequences and label the vials. Sticky labels with subject ID will be placed on an appropriate vial (zolendronic acid or placebo) for each patient. Allocation is therefore double blind. Vials of zolendronic acid and placebo are identical.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation by staff member naive to the trial.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2 / Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/2009
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Actual
10/07/2009
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Date of last participant enrolment
Anticipated
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Actual
10/12/2010
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Novartis
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Address [1]
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Novartis Pharmaceuticals Australia Pty Limited
54 Waterloo Road
North Ryde NSW 2113
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Menzies Research Institue
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Address
Private Bag 23
HOBART TAS 7000
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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none
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Address [1]
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none
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Tasmania Health & Medical Human Research Ethics Committee
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Ethics committee address [1]
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Office of Research Services
University of Tasmania
Private Bag 01
Hobart TAS 7001
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Ethics committee country [1]
239183
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Australia
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Date submitted for ethics approval [1]
239183
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Approval date [1]
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22/12/2008
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Ethics approval number [1]
239183
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EC00198
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Summary
Brief summary
Study rationale: Bone marrow oedema has recently been recognized to be a key correlate of knee pain. There is no known treatment for this problem but it is very common in those over 50 (30% of a random sample of 50-80 year olds in Hobart) (Zhai, 2006). There are no randomized trials but there is some observational evidence suggesting bisphosphonates modify this process. Firstly, they are much less common in population samples using bisphosphonates (OR 0.1) (Carbone 2004) and an open label study with IV ibandronate led to rapid resolution of hip bone marrow oedema (Ringe 2004) when natural history studies in the knee do not suggest resolution. Zoledronic acid is an attractive candidate for the treatment of this condition dues to its one off administration and potential for long term efficacy
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Trial website
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Trial related presentations / publications
Laslett LL, Doré DA, Quinn SJ, Boon P, Ryan E, Winzenberg TM, Jones G. Zoledronic acid reduces knee pain and bone marrow lesions over 1 year: a randomised controlled trial. Ann Rheum Dis. 2012 Aug;71(8):1322-8.
doi: 10.1136/annrheumdis-2011-200970.
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Public notes
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Contacts
Principal investigator
Name
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Prof Graeme Jones
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Address
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c/o Menzies Research Institute Tasmania
University of Tasmania
Private Bag 23
HOBART TAS 7000
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Country
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Australia
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Phone
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+61 3 6226 7700
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Professor Graeme Jones
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Address
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Private Bag 23
Hobart TAS 7001
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Country
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Australia
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Phone
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+61 3 6226 7700
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Fax
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+61 3 6226 7764
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Professor Graeme Jones
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Address
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Private Bag 23
Hobart TAS 7001
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Country
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Australia
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Phone
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+61 3 6226 7700
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Fax
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+61 3 6226 7764
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Zoledronic acid reduces knee pain and bone marrow lesions over 1 year: A randomised controlled trial.
2012
https://dx.doi.org/10.1136/annrheumdis-2011-200970
N.B. These documents automatically identified may not have been verified by the study sponsor.
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