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Trial registered on ANZCTR
Registration number
ACTRN12605000079640
Ethics application status
Approved
Date submitted
26/07/2005
Date registered
5/08/2005
Date last updated
8/10/2021
Date data sharing statement initially provided
8/10/2021
Date results information initially provided
8/10/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised double-blind placebo-controlled trial
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Scientific title
Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised trial
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute/subacute osteoporotic vertebral fractures (within 12 months of onset of symptoms)
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Musculoskeletal
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Osteoporosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The procedure used will be standardised across all sites (currently includes four hospitals in Melbourne, Cabrini, Alfred and Royal Melbourne Hospitals and Monash Medical Centre). Participants are randomly allocated to receive either a Vertebroplasty or Placebo Procedure. All participants will receive sedation/analgesia (midazolam and fentanyl), which will be administered by the radiologist performing the procedure. Participants undergoing vertebroplasty will have the left pedicle of the fracture vertebra infiltrated by a needle, which will be gently tapped into place using a hammer. The progress of the needle will be monitored so the correct position is determined. The bone cement (poly-methyl methacrylate) will be injected under Xray guidance, with the working time for the injection being approximately 2 minutes. A unilateral approach will be used unless there is inadequate instillation of cement, in which case a bipedicular approach will be used. Extreme care is taken to ensure that no leakage of cement occurs either into a vein or outside the bone. The injection will be stopped when significant resistance is met, when the cement reaches the posterior quarter of the vertebral body or when there is escape into extraosseous structures or veins. Only patients in the active group will receive antibiotics (Keflin) against infection. Both procedures take approximately 30-60 minutes.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
Placebo procedure. Participants undergoing the placebo with have the needle inserted to rest on the lamina and the tapping noise will be simulated. Cement will be mixed in the procedure room to recreate the smell.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Overall pain at 3 months
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Assessment method [1]
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Timepoint [1]
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Measured on a visual analogue scale at 3 months
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Secondary outcome [1]
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1. Pain at rest and in bed at night measured on a visual analogue scale.
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Assessment method [1]
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Timepoint [1]
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Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
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Secondary outcome [2]
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2. Assessment of Quality of Life Questionnaire (AQOL).
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Assessment method [2]
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Timepoint [2]
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Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
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Secondary outcome [3]
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3. Osteoporosis Quality of Life Questionnaire (QUALEFFO).
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Assessment method [3]
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Timepoint [3]
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Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
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Secondary outcome [4]
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4. Perceived Recovery measured on a 7 point ordinal scale ranging from 'a great deal worse' to 'a great deal better'.
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Assessment method [4]
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Timepoint [4]
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Measured at 1 week, 1, 3, 6, 12 and 24 months.
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Secondary outcome [5]
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5. Roland-Morris Low Back Pain and Disability Questionnaire.
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Assessment method [5]
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Timepoint [5]
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Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
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Secondary outcome [6]
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6. European Quality of Life (EUROQOL).
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Assessment method [6]
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Timepoint [6]
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Measured at baseline, 1 week, 1, 3, 6, 12 and 24 months.
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Secondary outcome [7]
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7. Incidence of subsequent vertebral fractures.
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Assessment method [7]
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Timepoint [7]
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Measured by X rays performed at 12 and 24 months.
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Secondary outcome [8]
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8. Timed up and go test, which is a reliable measure of function in older people.
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Assessment method [8]
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Timepoint [8]
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Measured at baseline, 12 and 24 months.
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Eligibility
Key inclusion criteria
1 or 2 acute painful osteoporotic spinal fracture/s confirmed on X ray with pain of no more than 12 months duration. Where more than one fracture is visible, vertebroplasty will only be performed on vertebral fractures that are acute according to MRI criteria (presence of oedema or fracture line within the vertebral body).
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Minimum age
Not stated
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Maximum age
Not stated
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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
Recent history of trauma, malignant disease in spine as determined by MRI, neurological complications, osteoporotic vertebral collapse of > 90%, contraindication to MRI, fracture through or destruction of the posterior wall, retropulsed bony fragment, pressure of bone fragments on the spinal cord, discitis, osteomyelitis, sepsis, uncorrectable coagulation disorder, medical conditions that would make the patient ineligible for emergency decompressive surgery should it be necessary to treat a procedure complication and inability to give informed consent.
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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)
The method of randomisation is by a sealed opaque envelope, opened by the treating radiologist prior to performing the procedure.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generatedRandomisation is by stratified allocation. Stratification factors are sex (M,F), duration of pain (less than or equal to 6 weeks pain, greater than 6 weeks pain) and hospital site.
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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
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Type of endpoint/s
Safety/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
1/10/2004
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Actual
1/04/2004
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Date of last participant enrolment
Anticipated
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Actual
30/10/2008
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Date of last data collection
Anticipated
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Actual
30/10/2010
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Sample size
Target
200
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Accrual to date
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Final
78
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC
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Address [1]
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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Arthritis Australia
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Address [2]
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Country [2]
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Australia
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Funding source category [3]
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Other
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Name [3]
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Education Institute
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Address [3]
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Country [3]
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Australia
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Funding source category [4]
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Commercial sector/Industry
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Name [4]
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Cook Australia
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Address [4]
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Country [4]
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Australia
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Primary sponsor type
University
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Name
Cabrini Research and Education Institute and Monash University
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Address
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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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N/A
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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23/12/2003
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Ethics approval number [1]
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Ethics committee name [2]
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Cabrini Research and Education Institute
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Ethics committee address [2]
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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Approval date [2]
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21/08/2003
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Ethics approval number [2]
1026
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Ethics committee name [3]
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The Alfred Hospital
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Ethics committee address [3]
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Ethics committee country [3]
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Australia
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Date submitted for ethics approval [3]
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Approval date [3]
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09/07/2004
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Ethics approval number [3]
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Ethics committee name [4]
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Melbourne Health
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Ethics committee address [4]
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Ethics committee country [4]
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Australia
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Date submitted for ethics approval [4]
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Approval date [4]
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17/03/2004
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Ethics approval number [4]
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Ethics committee name [5]
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Northern Health
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Ethics committee address [5]
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Ethics committee country [5]
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Australia
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Date submitted for ethics approval [5]
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Approval date [5]
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10/08/2004
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Ethics approval number [5]
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Ethics committee name [6]
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Southern Health
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Ethics committee address [6]
1030
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Ethics committee country [6]
1030
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Australia
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Date submitted for ethics approval [6]
1030
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Approval date [6]
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20/08/2004
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Ethics approval number [6]
1030
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt CJ, Wengier L, Connell D, Graves SE, Staples MP, Murphy B. Efficacy and safety of vertebroplasty for treatment of painful osteoporotic spinal fractures: a randomised controlled trial. [ACTRN012605000079640] BMC Musculoskeletal 2008; 9:156.
Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, Murphy B. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. New Engl J Med 2009; 261;557-68.
Staples MP, Kallmes DF, Comstock BA, Jarvik JG, Osborne RH, Heagarty PJ, Buchbinder R.
Effectiveness of vertebroplasty using individual patient data from two randomised placebo controlled trials: meta-analysis. BMJ 2011;342:d3952.
Kroon F, Staples MP, Ebeling P, Wark J, Osborne R, Mitchell P, Wriedt C, Buchbinder R. Vertebroplasty for osteoporotic vertebral fractures: Two-year results from a randomized controlled trial. J Bone Min Res 2014; 29 (6):1346-55.
Staples MP, Howe BM, Ringler M, Mitchell P, Wriedt C, Wark J, Ebeling P, Osborne R, Kallmes D, Buchbinder R. New vertebral fractures after vertebroplasty: 2-year results from a randomized controlled trial. Arch Osteoporosis 2015; 10(1):26.
Buchbinder R, Johnston R, Rischin KJ, Golmohammadi K, Jones A, Homik J, Kallmes DF. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture (Updated Review). Cochrane Database of Systematic Reviews 2018; Issue 11. Art. No.: CD006349.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ms Bridie Murphy
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Address
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Department of Clinical Epidemiology
Cabrini Medical Centre
Suite 41
183 Wattletree Road
Malvern VIC 3144
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Country
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Australia
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Phone
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+61 3 95081652
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Fax
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+61 3 95081653
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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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A/Prof Rachelle Buchbinder
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Address
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Department of Clinical Epidemiology
Cabrini Medical Centre
Suite 41
183 Wattletree Road
Malvern VIC 3144
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Country
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Australia
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Phone
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+61 3 95081652
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Fax
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+61 3 95081653
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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