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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00439647
Registration number
NCT00439647
Ethics application status
Date submitted
22/02/2007
Date registered
23/02/2007
Date last updated
21/04/2017
Titles & IDs
Public title
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
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Scientific title
A Two Year Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Fracture Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Annually for the Treatment of Osteoporosis in Men
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Secondary ID [1]
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0
CZOL446M2309
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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:
Male Osteoporosis
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic acid 5 mg iv
Treatment: Drugs - Placebo
Experimental: Zoledronic Acid - 5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
Placebo Comparator: Placebo - 100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
Treatment: Drugs: Zoledronic acid 5 mg iv
Zoledronic acid 5 mg iv given once a year.
Treatment: Drugs: Placebo
Placebo intravenous (i.v.) once a year
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months
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Assessment method [1]
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Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height
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Timepoint [1]
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24 Months
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Secondary outcome [1]
0
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Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months
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Assessment method [1]
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Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height
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Timepoint [1]
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12 Months
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Secondary outcome [2]
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Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months
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Assessment method [2]
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Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months
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Assessment method [3]
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Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.
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Timepoint [3]
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24 Months
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Secondary outcome [4]
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Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months
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Assessment method [4]
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Worsening vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)
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Timepoint [4]
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Baseline, 12 months
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Secondary outcome [5]
0
0
Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months
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Assessment method [5]
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Worsening vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)
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Timepoint [5]
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Baseline, Month 24
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Secondary outcome [6]
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Mean Change in Height From Baseline
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Assessment method [6]
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Height was measured using a stadiometer. Two measurements were taken in millimeters (mm), and repeated if the two measurements differed by greater than 4 mm. The average of the two (or four) height measurements was used for analysis
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Timepoint [6]
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from Baseline to 12 months and 24 months
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Secondary outcome [7]
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Number of Participants With First Clinical Vertebral Fracture
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Assessment method [7]
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Clinical vertebral fracture is a painful vertebral fracture which came to clinical attention, e.g., with increased back pain, impairment of mobility or functional limitations. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.
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Timepoint [7]
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24 months
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Secondary outcome [8]
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Number of Participants With First Clinical Fracture
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Assessment method [8]
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Clinical fracture is painful fracture in any site which came to clinical attention, e.g., with increased pain, impaired mobility or functional limitations. Subjects who did not experience fracture were censored at end of study. End of study was defined as the earlier of last visit or date of death.
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Timepoint [8]
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24 months
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Secondary outcome [9]
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Number of Participants With First Non-vertebral Fracture
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Assessment method [9]
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Non-vertebral fracture is any fracture which was not of the vertebrae. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.
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Timepoint [9]
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24 months
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Secondary outcome [10]
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Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)
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Assessment method [10]
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Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in BMD at lumbar spine at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)
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Timepoint [10]
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Month 6, Month 12, Month 24
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Secondary outcome [11]
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Percentage Change From Baseline in Total Hip BMD (g/CM^2)
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Assessment method [11]
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Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total hip BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)
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Timepoint [11]
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Month 6, Month 12, Month 24
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Secondary outcome [12]
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Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)
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Assessment method [12]
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Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total femoral neck BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100*(endpoint - baseline)
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Timepoint [12]
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Month 6, Month 12, Month 24
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Secondary outcome [13]
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Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits
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Assessment method [13]
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Timepoint [13]
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Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24
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Eligibility
Key inclusion criteria
• Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone
mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the
vertebrae
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Minimum age
50
Years
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Maximum age
85
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Low Vitamin D
- Renal insufficiency
- Previous treatment with certain anti-osteoporotic therapies (except after certain
washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium
fluoride, strontium ranelate,
- Previous treatment with testosterone, anabolic steroids or growth hormone
- Chronic use of systemic corticosteroids (oral or i.v.) within the last year
- History of any cancer or metastases within the last 5 years
- History of brittle bone disease, multiple myeloma, or Paget's disease, or any other
metabolic bone disease, except osteoporosis
- Bilateral hip replacements
Other protocol-defined inclusion/exclusion criteria may apply
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2010
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Sample size
Target
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Accrual to date
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Final
1199
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - Geelong-VIC
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Recruitment hospital [2]
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Novartis Investigative Site - Maroochydore-QLD
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Recruitment hospital [3]
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Novartis Investigative Site - Randwick-NSW
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Recruitment postcode(s) [1]
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- Geelong-VIC
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Recruitment postcode(s) [2]
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- Maroochydore-QLD
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Recruitment postcode(s) [3]
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- Randwick-NSW
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Mar del Plata
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Argentina
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San Miguel de Tucuman
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Austria
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Graz
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Austria
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Vienna
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Belgium
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Bruxelles
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Belgium
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Diepenbeek
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Belgium
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State/province [9]
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Genk
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Belgium
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State/province [10]
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Godinne
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Belgium
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Gozee
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Belgium
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Jette
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Belgium
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Laeken
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Belgium
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Leuven
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Belgium
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Liege
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Belgium
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Merksem
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Belgium
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Wilrijk
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Brazil
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Brasilia
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Brazil
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Curitiba
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Czechia
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Ceske Budejovice
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Czechia
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Hradec Kralove
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Czechia
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Plzen
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Aalborg
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Hvidovre
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Odense C
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Finland
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Helsinki
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Finland
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Tampere
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Finland
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Turku
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Germany
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Aachen
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Germany
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Bad Bentheim
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Germany
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Bad Pyrmont
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Germany
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Braunfels
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Germany
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Dresden
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Kempen
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Germany
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Leverkusen
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Germany
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Magdeburg
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Germany
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Marburg
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Germany
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München
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Germany
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Würzburg
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Hungary
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Veszprem
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Iceland
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Kopavogur
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Italy
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Arenzano
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Italy
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Siena-SI
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Italy
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Valeggio Sul Mincio
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Norway
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Elverum
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Norway
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Gjettum
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Norway
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Hamar
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Norway
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Oslo
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0
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Norway
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Paradis
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Norway
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Trondheim
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Poland
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Bialystok
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Poland
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Warszawa
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Portugal
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Lisbon
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Portugal
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Ponte de Lima
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0
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Romania
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Bucharest
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0
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Romania
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Cluj Napoca
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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0
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Russian Federation
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Tyumen
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0
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Russian Federation
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0
Yaroslavl
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0
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Russian Federation
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State/province [76]
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Yekaterinburg
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0
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Lubochna
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Slovakia
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Piestany
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South Africa
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Cape Town
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South Africa
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Rosebank-Johannesburg
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South Africa
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Western Cape
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Cordoba
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0
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Spain
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0
Granada
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0
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Spain
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0
Hospitalet de Llobregat
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0
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Spain
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0
Madrid
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0
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Spain
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0
Malaga
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0
0
Spain
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State/province [92]
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Merida
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Spain
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Oviedo
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Spain
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Sabadell
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Spain
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Salamanca
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Villajoyosa
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Sweden
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Gothenburg
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Sweden
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Linkoeping
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Sweden
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Lund
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Sweden
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Malmo
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Sweden
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Orebro
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Sweden
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Stockholm
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Sweden
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Umea
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Sweden
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Uppsala
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Switzerland
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Aarau
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Switzerland
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Baden
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Geneve
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Switzerland
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Lausanne
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Switzerland
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Sion
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Switzerland
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Zuerich
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United Kingdom
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Aberdeen
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United Kingdom
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Chorley
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United Kingdom
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Glasgow
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United Kingdom
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Kent
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United Kingdom
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Liverpool
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United Kingdom
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Manchester
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United Kingdom
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Middx
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Nottingham
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United Kingdom
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Penarth
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United Kingdom
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Reading-Berkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
This study will investigate if the drug zoledronic acid given once yearly is safe and has
beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with
osteoporosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00439647
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Argentina
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00439647
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