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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/NCT01631214
Registration number
NCT01631214
Ethics application status
Date submitted
24/05/2012
Date registered
29/06/2012
Date last updated
8/11/2022
Titles & IDs
Public title
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
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Scientific title
A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
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Secondary ID [1]
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2011-003142-41
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Secondary ID [2]
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20110142
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Universal Trial Number (UTN)
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Trial acronym
ARCH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postmenopausal Women With 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
Other interventions - Romosozumab
Treatment: Drugs - Alendronate
Treatment: Drugs - Placebo to Romosozumab
Treatment: Drugs - Placebo to Alendronate
Active Comparator: Alendronate/Alendronate - Participants received 70 mg alendronate once a week and placebo to romosozumab subcutaneously once a month for the first 12 months. After completion of the 12-month double-blind treatment period participants continued to receive 70 mg alendronate once a week until the end of the study.
Experimental: Romosozumab/Alendronate - Participants received 210 mg romosozumab subcutaneously once a month and placebo to alendronate orally once a week for the first 12 months. After completion of the 12-month double-blind treatment period participants received 70 mg alendronate once a week until the end of the study.
Other interventions: Romosozumab
Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.
Treatment: Drugs: Alendronate
Alendronate 70 mg tablet taken once a week
Treatment: Drugs: Placebo to Romosozumab
Administered by subcutaneous injection once a month during the double-blind treatment phase.
Treatment: Drugs: Placebo to Alendronate
Matching placebo tablet taken once a week during the double-blind treatment phase.
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Intervention code [1]
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Other interventions
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Intervention code [2]
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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 New Vertebral Fractures Through Month 24
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Assessment method [1]
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All fracture assessments were performed by blinded central imaging readers.
New vertebral fractures occurred when there was = 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:
Grade 0 (Normal) = no fracture;
Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.
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Timepoint [1]
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24 months
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Primary outcome [2]
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Percentage of Participants With a Clinical Fracture at the Primary Analysis
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Assessment method [2]
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All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.
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Timepoint [2]
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The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
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Secondary outcome [1]
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Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis
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Assessment method [1]
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A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
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Timepoint [1]
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The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
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Secondary outcome [2]
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Percentage of Participants With Any Fracture at the Primary Analysis
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Assessment method [2]
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All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.
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Timepoint [2]
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The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
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Secondary outcome [3]
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Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24
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Assessment method [3]
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A new or worsening vertebral fracture was identified when there was a = 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:
Grade 0 (Normal) = no fracture;
Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method.
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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 a Major Nonvertebral Fracture at the Primary Analysis
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Assessment method [4]
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Major nonvertebral fractures included a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.
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Timepoint [4]
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The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
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Secondary outcome [5]
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Percentage of Participants With a Hip Fracture at the Primary Analysis
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Assessment method [5]
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Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
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Timepoint [5]
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The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).
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Secondary outcome [6]
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Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24
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Assessment method [6]
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A new or worsening vertebral fracture was identified when there was a = 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method. A participant had multiple new or worsening vertebral fractures when there were = 2 vertebrae from T4 to L4 with = 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. Incident vertebral fractures were confirmed by a second independent reader.
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Timepoint [6]
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24 months
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Secondary outcome [7]
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Percentage of Participants With a Clinical Fracture Through Month 24
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Assessment method [7]
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Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.
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Timepoint [7]
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24 months
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Secondary outcome [8]
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Percentage of Participants With a Nonvertebral Fracture Through Month 24
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Assessment method [8]
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A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
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Timepoint [8]
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24 months
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Secondary outcome [9]
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Percentage of Participants With a Hip Fracture Through Month 24
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Assessment method [9]
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Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
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Timepoint [9]
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24 months
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Secondary outcome [10]
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Percentage of Participants With a Clinical Vertebral Fracture Through Month 24
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Assessment method [10]
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A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.
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Timepoint [10]
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24 months
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Secondary outcome [11]
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Percentage of Participants With a Clinical Fracture Through Month 12
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Assessment method [11]
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Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.
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Timepoint [11]
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12 months
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Secondary outcome [12]
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Percentage of Participants With New Vertebral Fractures Through Month 12
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Assessment method [12]
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New vertebral fractures occurred when there was = 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:
Grade 0 (Normal) = no fracture;
Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);
Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;
Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.
Incident vertebral fractures were confirmed by a second independent reader.
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Timepoint [12]
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12 months
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Secondary outcome [13]
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Percentage of Participants With Any Fracture Through Month 12
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Assessment method [13]
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All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.
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Timepoint [13]
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12 months
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Secondary outcome [14]
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Percentage of Participants With a Nonvertebral Fracture Through Month 12
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Assessment method [14]
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A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
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Timepoint [14]
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12 months
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Secondary outcome [15]
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Percentage of Participants With a Hip Fracture Through Month 12
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Assessment method [15]
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Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.
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Timepoint [15]
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12 months
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Secondary outcome [16]
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Percentage of Participants With a Major Osteoporotic Fracture Through Month 12
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Assessment method [16]
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Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.
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Timepoint [16]
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12 months
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Secondary outcome [17]
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Percentage of Participants With a Clinical Vertebral Fracture Through Month 12
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Assessment method [17]
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A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.
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Timepoint [17]
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12 months
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Secondary outcome [18]
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Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24
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Assessment method [18]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [18]
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Baseline and month 24
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Secondary outcome [19]
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Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24
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Assessment method [19]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [19]
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Baseline and month 24
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Secondary outcome [20]
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Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24
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Assessment method [20]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [20]
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Baseline and month 24
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Secondary outcome [21]
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Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12
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Assessment method [21]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [21]
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Baseline and month 12
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Secondary outcome [22]
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Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12
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Assessment method [22]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [22]
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Baseline and month 12
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Secondary outcome [23]
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Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12
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Assessment method [23]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [23]
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Baseline and month 12
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Secondary outcome [24]
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Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36
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Assessment method [24]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [24]
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Baseline and month 36
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Secondary outcome [25]
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Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36
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Assessment method [25]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [25]
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Baseline and month 36
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Secondary outcome [26]
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Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36
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Assessment method [26]
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Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.
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Timepoint [26]
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Baseline and month 36
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Eligibility
Key inclusion criteria
Postmenopausal women who meet at least one of the following bone mineral density (BMD) and
fracture criteria:
- BMD T-score at the total hip or femoral neck of = -2.50 and EITHER:
- at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral
fracture OR
- at least 2 mild (SQ1) vertebral fractures OR
- BMD T-score at the total hip or femoral neck of = -2.00 and EITHER:
- at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR
- a fracture of the proximal femur that occurred within 3 to 24 months prior to
randomization.
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Minimum age
55
Years
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Maximum age
90
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of metabolic or bone disease (except osteoporosis)
- Use of agents affecting bone metabolism
- Vitamin D insufficiency
- History of solid organ or bone marrow transplants
- Hyper- or hypocalcemia
- Hyper- or hypothyroidism
- Hyper- or hypoparathyroidism
- Possible signs of intolerance to alendronate
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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
4/05/2012
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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
29/06/2017
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Sample size
Target
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Accrual to date
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Final
4093
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Research Site - Darlinghurst
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Recruitment hospital [2]
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Research Site - Kogarah
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Recruitment hospital [3]
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Research Site - Randwick
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Recruitment hospital [4]
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Research Site - Box Hill
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Recruitment hospital [5]
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Research Site - Geelong
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Recruitment hospital [6]
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Research Site - Heidelberg West
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Recruitment hospital [7]
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Research Site - Parkville
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment postcode(s) [6]
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3081 - Heidelberg West
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Recruitment postcode(s) [7]
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3050 - Parkville
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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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Alabama
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0
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United States of America
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State/province [2]
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Arizona
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0
0
United States of America
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State/province [3]
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California
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0
0
United States of America
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State/province [4]
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Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
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Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Indiana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Maryland
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Massachusetts
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Michigan
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Country [12]
0
0
United States of America
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State/province [12]
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Missouri
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Country [13]
0
0
United States of America
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State/province [13]
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0
Nevada
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0
0
United States of America
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State/province [14]
0
0
New Mexico
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Country [15]
0
0
United States of America
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State/province [15]
0
0
New York
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Country [16]
0
0
United States of America
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State/province [16]
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North Dakota
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0
United States of America
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Pennsylvania
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0
0
United States of America
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Virginia
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0
0
United States of America
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Washington
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0
0
United States of America
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Wisconsin
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Country [21]
0
0
Argentina
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State/province [21]
0
0
Buenos Aires
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Country [22]
0
0
Argentina
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State/province [22]
0
0
Córdoba
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Country [23]
0
0
Austria
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0
0
Graz
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Country [24]
0
0
Austria
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State/province [24]
0
0
Linz
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0
0
Austria
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0
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Wien
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0
0
Belgium
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0
0
Brugge
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0
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Belgium
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Bruxelles
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0
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Belgium
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Genk
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Belgium
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0
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Gent
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Belgium
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Leuven
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Belgium
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Liège
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Brazil
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Ceará
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Brazil
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Distrito Federal
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Brazil
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Espírito Santo
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0
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Brazil
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0
0
Goiás
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0
0
Brazil
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0
0
Paraná
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0
0
Brazil
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0
0
Pernambuco
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0
0
Brazil
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0
0
Rio de Janeiro
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0
0
Brazil
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0
0
São Paulo
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0
0
Bulgaria
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0
Plovdiv
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0
0
Bulgaria
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0
0
Sofia
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0
0
Canada
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0
0
British Columbia
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0
0
Canada
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0
0
Manitoba
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0
0
Canada
Query!
State/province [44]
0
0
Newfoundland and Labrador
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Nova Scotia
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Ontario
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Quebec
Query!
Country [48]
0
0
Chile
Query!
State/province [48]
0
0
Santiago
Query!
Country [49]
0
0
Colombia
Query!
State/province [49]
0
0
Antioquia
Query!
Country [50]
0
0
Colombia
Query!
State/province [50]
0
0
Atlántico
Query!
Country [51]
0
0
Colombia
Query!
State/province [51]
0
0
Cundinamarca
Query!
Country [52]
0
0
Colombia
Query!
State/province [52]
0
0
Bogota
Query!
Country [53]
0
0
Colombia
Query!
State/province [53]
0
0
Bucaramanga
Query!
Country [54]
0
0
Czechia
Query!
State/province [54]
0
0
Brno
Query!
Country [55]
0
0
Czechia
Query!
State/province [55]
0
0
Hradec Kralove
Query!
Country [56]
0
0
Czechia
Query!
State/province [56]
0
0
Klatovy
Query!
Country [57]
0
0
Czechia
Query!
State/province [57]
0
0
Opava
Query!
Country [58]
0
0
Czechia
Query!
State/province [58]
0
0
Ostrava-Trebovice
Query!
Country [59]
0
0
Czechia
Query!
State/province [59]
0
0
Pardubice
Query!
Country [60]
0
0
Czechia
Query!
State/province [60]
0
0
Plzen
Query!
Country [61]
0
0
Czechia
Query!
State/province [61]
0
0
Praha 2
Query!
Country [62]
0
0
Czechia
Query!
State/province [62]
0
0
Praha 3
Query!
Country [63]
0
0
Czechia
Query!
State/province [63]
0
0
Uherske Hradiste
Query!
Country [64]
0
0
Czechia
Query!
State/province [64]
0
0
Zlin
Query!
Country [65]
0
0
Denmark
Query!
State/province [65]
0
0
Aalborg
Query!
Country [66]
0
0
Denmark
Query!
State/province [66]
0
0
Ballerup
Query!
Country [67]
0
0
Denmark
Query!
State/province [67]
0
0
Glostrup
Query!
Country [68]
0
0
Denmark
Query!
State/province [68]
0
0
Hvidovre
Query!
Country [69]
0
0
Denmark
Query!
State/province [69]
0
0
Koge
Query!
Country [70]
0
0
Denmark
Query!
State/province [70]
0
0
Odense
Query!
Country [71]
0
0
Denmark
Query!
State/province [71]
0
0
Vejle
Query!
Country [72]
0
0
Denmark
Query!
State/province [72]
0
0
Århus C
Query!
Country [73]
0
0
Dominican Republic
Query!
State/province [73]
0
0
Distrito Nacional
Query!
Country [74]
0
0
Dominican Republic
Query!
State/province [74]
0
0
Santiago
Query!
Country [75]
0
0
Dominican Republic
Query!
State/province [75]
0
0
Santo Domingo
Query!
Country [76]
0
0
Estonia
Query!
State/province [76]
0
0
Tallinn
Query!
Country [77]
0
0
Estonia
Query!
State/province [77]
0
0
Tartu
Query!
Country [78]
0
0
Finland
Query!
State/province [78]
0
0
Helsinki
Query!
Country [79]
0
0
Finland
Query!
State/province [79]
0
0
Jyväskylä
Query!
Country [80]
0
0
Finland
Query!
State/province [80]
0
0
Kuopio
Query!
Country [81]
0
0
Finland
Query!
State/province [81]
0
0
Turku
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Bordeaux Cedex
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Cahors Cedex
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Lille cedex
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Lyon Cédex 3
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Orleans Cedex
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Saint Priest en Jarez
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Toulouse Cedex 9
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Vandoeuvre les Nancy
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Berlin (Hellersdorf)
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Berlin
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Bonn
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Dresden
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Frankfurt am Main
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Freiburg
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Hamburg
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Hannover
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Heinsberg
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Leipzig
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Magdeburg
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Marburg
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
München
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Würzburg
Query!
Country [104]
0
0
Greece
Query!
State/province [104]
0
0
Athens
Query!
Country [105]
0
0
Greece
Query!
State/province [105]
0
0
Larissa
Query!
Country [106]
0
0
Greece
Query!
State/province [106]
0
0
Thessaloniki
Query!
Country [107]
0
0
Guatemala
Query!
State/province [107]
0
0
Sacatepéquez
Query!
Country [108]
0
0
Guatemala
Query!
State/province [108]
0
0
Guatemala
Query!
Country [109]
0
0
Hong Kong
Query!
State/province [109]
0
0
Hong Kong
Query!
Country [110]
0
0
Hong Kong
Query!
State/province [110]
0
0
New Territories
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Balatonfured
Query!
Country [112]
0
0
Hungary
Query!
State/province [112]
0
0
Bekescsaba
Query!
Country [113]
0
0
Hungary
Query!
State/province [113]
0
0
Budapest
Query!
Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Debrecen
Query!
Country [115]
0
0
Hungary
Query!
State/province [115]
0
0
Gyor
Query!
Country [116]
0
0
Hungary
Query!
State/province [116]
0
0
Kaposvar
Query!
Country [117]
0
0
Hungary
Query!
State/province [117]
0
0
Kiskunhalas
Query!
Country [118]
0
0
Hungary
Query!
State/province [118]
0
0
Kistarcsa
Query!
Country [119]
0
0
Hungary
Query!
State/province [119]
0
0
Veszprem
Query!
Country [120]
0
0
Hungary
Query!
State/province [120]
0
0
Zalaegerszeg
Query!
Country [121]
0
0
Ireland
Query!
State/province [121]
0
0
Cork
Query!
Country [122]
0
0
Ireland
Query!
State/province [122]
0
0
Dublin
Query!
Country [123]
0
0
Ireland
Query!
State/province [123]
0
0
Galway
Query!
Country [124]
0
0
Israel
Query!
State/province [124]
0
0
Bnei Brak
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
Haifa
Query!
Country [126]
0
0
Israel
Query!
State/province [126]
0
0
Jerusalem
Query!
Country [127]
0
0
Israel
Query!
State/province [127]
0
0
Tel Aviv
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Arenzano GE
Query!
Country [129]
0
0
Italy
Query!
State/province [129]
0
0
Bologna
Query!
Country [130]
0
0
Italy
Query!
State/province [130]
0
0
Catania
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Firenze
Query!
Country [132]
0
0
Italy
Query!
State/province [132]
0
0
Milan
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Pisa
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Roma
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Siena
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Torino
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Verona
Query!
Country [138]
0
0
Korea, Republic of
Query!
State/province [138]
0
0
Daegu
Query!
Country [139]
0
0
Korea, Republic of
Query!
State/province [139]
0
0
Guri-si
Query!
Country [140]
0
0
Korea, Republic of
Query!
State/province [140]
0
0
Gwangju
Query!
Country [141]
0
0
Korea, Republic of
Query!
State/province [141]
0
0
Incheon
Query!
Country [142]
0
0
Korea, Republic of
Query!
State/province [142]
0
0
Seoul
Query!
Country [143]
0
0
Korea, Republic of
Query!
State/province [143]
0
0
Suwon-si, Gyeonggi-do
Query!
Country [144]
0
0
Latvia
Query!
State/province [144]
0
0
Liepaja
Query!
Country [145]
0
0
Latvia
Query!
State/province [145]
0
0
Riga
Query!
Country [146]
0
0
Lithuania
Query!
State/province [146]
0
0
Vilnius
Query!
Country [147]
0
0
Mexico
Query!
State/province [147]
0
0
Baja California Norte
Query!
Country [148]
0
0
Mexico
Query!
State/province [148]
0
0
Distrito Federal
Query!
Country [149]
0
0
Mexico
Query!
State/province [149]
0
0
Guanajuato
Query!
Country [150]
0
0
Mexico
Query!
State/province [150]
0
0
Nuevo León
Query!
Country [151]
0
0
Mexico
Query!
State/province [151]
0
0
Querétaro
Query!
Country [152]
0
0
Mexico
Query!
State/province [152]
0
0
Sonora
Query!
Country [153]
0
0
Netherlands
Query!
State/province [153]
0
0
Leiden
Query!
Country [154]
0
0
Netherlands
Query!
State/province [154]
0
0
Rotterdam
Query!
Country [155]
0
0
Netherlands
Query!
State/province [155]
0
0
Venlo
Query!
Country [156]
0
0
New Zealand
Query!
State/province [156]
0
0
Christchurch
Query!
Country [157]
0
0
New Zealand
Query!
State/province [157]
0
0
Grafton, Auckland
Query!
Country [158]
0
0
Norway
Query!
State/province [158]
0
0
Elverum
Query!
Country [159]
0
0
Norway
Query!
State/province [159]
0
0
Hamar
Query!
Country [160]
0
0
Norway
Query!
State/province [160]
0
0
Oslo
Query!
Country [161]
0
0
Norway
Query!
State/province [161]
0
0
Stavanger
Query!
Country [162]
0
0
Peru
Query!
State/province [162]
0
0
Lima
Query!
Country [163]
0
0
Poland
Query!
State/province [163]
0
0
Bialystok
Query!
Country [164]
0
0
Poland
Query!
State/province [164]
0
0
Dabrowka Dopiewo
Query!
Country [165]
0
0
Poland
Query!
State/province [165]
0
0
Elblag
Query!
Country [166]
0
0
Poland
Query!
State/province [166]
0
0
Gdynia
Query!
Country [167]
0
0
Poland
Query!
State/province [167]
0
0
Gliwice
Query!
Country [168]
0
0
Poland
Query!
State/province [168]
0
0
Katowice
Query!
Country [169]
0
0
Poland
Query!
State/province [169]
0
0
Kielce
Query!
Country [170]
0
0
Poland
Query!
State/province [170]
0
0
Krakow
Query!
Country [171]
0
0
Poland
Query!
State/province [171]
0
0
Kraków
Query!
Country [172]
0
0
Poland
Query!
State/province [172]
0
0
Lodz
Query!
Country [173]
0
0
Poland
Query!
State/province [173]
0
0
Poznan
Query!
Country [174]
0
0
Poland
Query!
State/province [174]
0
0
Swidnik
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Torun
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Warszawa
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Wroclaw
Query!
Country [178]
0
0
Romania
Query!
State/province [178]
0
0
Bucharest
Query!
Country [179]
0
0
Romania
Query!
State/province [179]
0
0
Bucuresti
Query!
Country [180]
0
0
Romania
Query!
State/province [180]
0
0
Oradea
Query!
Country [181]
0
0
Romania
Query!
State/province [181]
0
0
Targu Mures
Query!
Country [182]
0
0
Russian Federation
Query!
State/province [182]
0
0
Arkhangelsk
Query!
Country [183]
0
0
Russian Federation
Query!
State/province [183]
0
0
Ekaterinburg
Query!
Country [184]
0
0
Russian Federation
Query!
State/province [184]
0
0
Ivanovo
Query!
Country [185]
0
0
Russian Federation
Query!
State/province [185]
0
0
Moscow
Query!
Country [186]
0
0
Russian Federation
Query!
State/province [186]
0
0
Nizhniy Novgorod
Query!
Country [187]
0
0
Russian Federation
Query!
State/province [187]
0
0
Petrozavodsk
Query!
Country [188]
0
0
Russian Federation
Query!
State/province [188]
0
0
Saint Petersburg
Query!
Country [189]
0
0
Russian Federation
Query!
State/province [189]
0
0
Saint-Petersburg
Query!
Country [190]
0
0
Russian Federation
Query!
State/province [190]
0
0
Yaroslavl
Query!
Country [191]
0
0
Slovakia
Query!
State/province [191]
0
0
Banska Bystrica
Query!
Country [192]
0
0
Slovakia
Query!
State/province [192]
0
0
Bratislava
Query!
Country [193]
0
0
Slovakia
Query!
State/province [193]
0
0
Kosice-Saca
Query!
Country [194]
0
0
Slovakia
Query!
State/province [194]
0
0
Lucenec
Query!
Country [195]
0
0
Slovakia
Query!
State/province [195]
0
0
Piestany
Query!
Country [196]
0
0
Slovakia
Query!
State/province [196]
0
0
Trencin
Query!
Country [197]
0
0
South Africa
Query!
State/province [197]
0
0
Gauteng
Query!
Country [198]
0
0
South Africa
Query!
State/province [198]
0
0
Western Cape
Query!
Country [199]
0
0
South Africa
Query!
State/province [199]
0
0
Tygerberg
Query!
Country [200]
0
0
Spain
Query!
State/province [200]
0
0
Andalucía
Query!
Country [201]
0
0
Spain
Query!
State/province [201]
0
0
Cantabria
Query!
Country [202]
0
0
Spain
Query!
State/province [202]
0
0
Cataluña
Query!
Country [203]
0
0
Spain
Query!
State/province [203]
0
0
Galicia
Query!
Country [204]
0
0
Spain
Query!
State/province [204]
0
0
Madrid
Query!
Country [205]
0
0
Sweden
Query!
State/province [205]
0
0
Linköping
Query!
Country [206]
0
0
Sweden
Query!
State/province [206]
0
0
Mölndal
Query!
Country [207]
0
0
Sweden
Query!
State/province [207]
0
0
Stockholm
Query!
Country [208]
0
0
Sweden
Query!
State/province [208]
0
0
Umeå
Query!
Country [209]
0
0
Taiwan
Query!
State/province [209]
0
0
Tainan
Query!
Country [210]
0
0
Taiwan
Query!
State/province [210]
0
0
Taipei
Query!
Country [211]
0
0
Turkey
Query!
State/province [211]
0
0
Adana
Query!
Country [212]
0
0
Turkey
Query!
State/province [212]
0
0
Istanbul
Query!
Country [213]
0
0
Turkey
Query!
State/province [213]
0
0
Izmir
Query!
Country [214]
0
0
United Kingdom
Query!
State/province [214]
0
0
Birmingham
Query!
Country [215]
0
0
United Kingdom
Query!
State/province [215]
0
0
Cambridge
Query!
Country [216]
0
0
United Kingdom
Query!
State/province [216]
0
0
Cardiff
Query!
Country [217]
0
0
United Kingdom
Query!
State/province [217]
0
0
Chorley
Query!
Country [218]
0
0
United Kingdom
Query!
State/province [218]
0
0
Edinburgh
Query!
Country [219]
0
0
United Kingdom
Query!
State/province [219]
0
0
Glasgow
Query!
Country [220]
0
0
United Kingdom
Query!
State/province [220]
0
0
Liverpool
Query!
Country [221]
0
0
United Kingdom
Query!
State/province [221]
0
0
Manchester
Query!
Country [222]
0
0
United Kingdom
Query!
State/province [222]
0
0
Northwood
Query!
Country [223]
0
0
United Kingdom
Query!
State/province [223]
0
0
Norwich
Query!
Country [224]
0
0
United Kingdom
Query!
State/province [224]
0
0
Reading
Query!
Country [225]
0
0
United Kingdom
Query!
State/province [225]
0
0
Sheffield
Query!
Country [226]
0
0
United Kingdom
Query!
State/province [226]
0
0
Sidcup
Query!
Country [227]
0
0
United Kingdom
Query!
State/province [227]
0
0
Staffordshire
Query!
Country [228]
0
0
United Kingdom
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Warwick
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine if treatment is effective in preventing fractures
in women with postmenopausal osteoporosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01631214
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Trial related presentations / publications
Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.
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Public notes
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Contacts
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MD
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01631214
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