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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00247273
Registration number
NCT00247273
Ethics application status
Date submitted
28/10/2005
Date registered
1/11/2005
Date last updated
22/04/2013
Titles & IDs
Public title
A Study of Monthly Risedronate for Osteoporosis
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Scientific title
A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
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Secondary ID [1]
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EFC6062 AND HMRF004M/3001
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Secondary ID [2]
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2005032
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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:
Postmenopausal Osteoporosis
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Condition category
Condition code
Musculoskeletal
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Osteoporosis
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Reproductive Health and Childbirth
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - risedronate
Treatment: Drugs - risedronate
Active comparator: 1 - 5 mg risedronate, once daily for 2 years
Experimental: 2 - 150 mg risedronate taken once a month for 2 years
Treatment: Drugs: risedronate
tablet, 5 mg risedronate, once a day for 2 years
Treatment: Drugs: risedronate
oral, 150 mg risedronate, once a month for 2 years
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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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Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
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Assessment method [1]
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BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
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Timepoint [1]
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Baseline to Month 12 - Endpoint
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Secondary outcome [1]
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Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
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Assessment method [1]
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BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
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Timepoint [1]
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Baseline to Month 12
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Secondary outcome [2]
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Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
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Assessment method [2]
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BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
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Timepoint [2]
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Baseline to Month 12
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Secondary outcome [3]
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Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
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Assessment method [3]
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BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).
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Timepoint [3]
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Baseline to Month 24 - Endpoint
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Secondary outcome [4]
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Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
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Assessment method [4]
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BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
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Timepoint [4]
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Baseline to Month 24
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Secondary outcome [5]
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Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
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Assessment method [5]
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BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
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Timepoint [5]
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Baseline to Month 24
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Secondary outcome [6]
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Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
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Assessment method [6]
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Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine
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Timepoint [6]
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Baseline to Month 6
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Secondary outcome [7]
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Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
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Assessment method [7]
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Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24.
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Timepoint [7]
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Baseline to Month 6
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Secondary outcome [8]
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Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
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Assessment method [8]
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Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24.
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Timepoint [8]
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Baseline to Month 24
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Secondary outcome [9]
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Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
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Assessment method [9]
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Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 \& 24.
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Timepoint [9]
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Baseline to Month 24
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Secondary outcome [10]
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Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
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Assessment method [10]
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ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.
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Timepoint [10]
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Baseline to Month 6
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Secondary outcome [11]
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Percent Change From Baseline in Serum CTX at Month 6, ITT Population
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Assessment method [11]
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Assayed by electrochemiluminescent immunoassay.
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Timepoint [11]
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Baseline to Month 6
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Secondary outcome [12]
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Change From Baseline in Serum CTX at Month 24, ITT Population
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Assessment method [12]
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Assayed by electrochemiluminescent immunoassay.
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Timepoint [12]
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Baseline to Month 24
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Secondary outcome [13]
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Percent Change From Baseline in Serum CTX at Month 24, ITT Population
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Assessment method [13]
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Assayed by electrochemiluminescent immunoassay.
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Timepoint [13]
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Baseline to Month 24
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Secondary outcome [14]
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Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
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Assessment method [14]
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ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)
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Timepoint [14]
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Baseline to Month 6
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Secondary outcome [15]
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Percent Change From Baseline in Serum BAP at Month 6, ITT Population
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Assessment method [15]
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Assayed by ELISA (enzyme-linked immunosorbent assay)
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Timepoint [15]
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Baseline to Month 6
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Secondary outcome [16]
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Change From Baseline in Serum BAP at Month 24, ITT Population
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Assessment method [16]
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Assayed by ELISA (enzyme-linked immunosorbent assay)
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Timepoint [16]
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Baseline to Month 24
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Secondary outcome [17]
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Percent Change From Baseline in Serum BAP at Month 24, ITT Population
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Assessment method [17]
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Assayed by ELISA (enzyme-linked immunosorbent assay)
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Timepoint [17]
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Baseline to Month 24
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Secondary outcome [18]
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Number of Participants With New Vertebral Fracture at Month 12, ITT Population
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Assessment method [18]
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At least 1 new fractured vertebra
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Timepoint [18]
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Baseline to Month 12
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Secondary outcome [19]
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Number of Participants With New Vertebral Fracture at Month 24, ITT Population
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Assessment method [19]
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At least 1 new fractured vertebra
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Timepoint [19]
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Baseline to Month 24
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Eligibility
Key inclusion criteria
* Female: 50 years of age or older
* >5 years since last menses natural or surgical
* have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
* BMI (body mass index) >32 kg/m^2
* use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
* hypocalcemia or hypercalcemia of any cause
* markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
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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 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
1/10/2005
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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
1/04/2008
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Sample size
Target
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Accrual to date
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Final
1294
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Geelong
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Recruitment hospital [2]
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Research Site - Heidelberg, Victoria
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Recruitment hospital [3]
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Research Site - Saint Leonards
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Recruitment postcode(s) [1]
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- Geelong
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Recruitment postcode(s) [2]
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- Heidelberg, Victoria
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Recruitment postcode(s) [3]
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- Saint Leonards
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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United States of America
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State/province [2]
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Georgia
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Country [3]
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United States of America
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State/province [3]
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Maryland
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Country [4]
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United States of America
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State/province [4]
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Nebraska
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Oregon
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Country [8]
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Argentina
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State/province [8]
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Buenos Aires
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Country [9]
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Argentina
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State/province [9]
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Capital Federal
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Country [10]
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Belgium
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State/province [10]
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Brussels
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Country [11]
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Belgium
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State/province [11]
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Gent
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Country [12]
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Belgium
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State/province [12]
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Leuven
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Country [13]
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Belgium
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State/province [13]
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Liege
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Country [14]
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Belgium
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State/province [14]
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Mont Godinne
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Country [15]
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Brazil
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State/province [15]
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Rio de Janeiro
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Country [16]
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Brazil
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State/province [16]
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Sao Paulo
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Country [17]
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Canada
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State/province [17]
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Calgary
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Country [18]
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Canada
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State/province [18]
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Montreal
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Country [19]
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Canada
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State/province [19]
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Sainte Foy
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Country [20]
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Canada
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State/province [20]
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Saskatoon
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Country [21]
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Estonia
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State/province [21]
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Parnu
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Country [22]
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Estonia
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State/province [22]
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Tartu
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Country [23]
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Finland
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State/province [23]
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Helsinki
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Country [24]
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Finland
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State/province [24]
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Kuopio
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Country [25]
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Finland
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State/province [25]
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Oulu
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Country [26]
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Finland
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State/province [26]
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Turku
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Country [27]
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France
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State/province [27]
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Amiens Cedex 1
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Country [28]
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France
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State/province [28]
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Lyon Cedex
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Country [29]
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France
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State/province [29]
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Orleans
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Country [30]
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France
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State/province [30]
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Paris
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Country [31]
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France
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State/province [31]
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Toulouse
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Country [32]
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France
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State/province [32]
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Vandoeuvre Les Nancy
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Country [33]
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Hungary
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State/province [33]
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Balatonfured
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Country [34]
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Hungary
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State/province [34]
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Budapest
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Country [35]
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Hungary
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State/province [35]
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Gyor
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Country [36]
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Hungary
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State/province [36]
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Miskolc
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Country [37]
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Hungary
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State/province [37]
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Nagykanizs
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Country [38]
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Lebanon
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State/province [38]
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Beirut
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Country [39]
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Norway
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State/province [39]
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Oslo
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Country [40]
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Norway
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State/province [40]
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Paradis
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Country [41]
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Norway
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State/province [41]
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Trondheim
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Country [42]
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Poland
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State/province [42]
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Bialystok
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Country [43]
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Poland
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State/province [43]
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Warszawa
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Country [44]
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Spain
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State/province [44]
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Barcelona
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Country [45]
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Spain
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State/province [45]
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Granada
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Country [46]
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Spain
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State/province [46]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Warner Chilcott
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Sanofi
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
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Trial website
https://clinicaltrials.gov/study/NCT00247273
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sal Bartelmo, MD
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Address
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P&G
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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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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 scientific queries
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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00247273
Download to PDF