Central Review of Radiographs and DXA Scans Sample Clauses

Central Review of Radiographs and DXA Scans. All radiographs will be viewed and assessed by a blinded, independent assessor (radiologist) on the basis of existing baseline and study-acquired vertebral deformity, and fractures will be assessed according to the method of Genant. A second blinded radiologist will review the assessment of the first reviewer for all subject radiographs in which an incident fracture has been identified. In the case of any disagreement, a third consensus assessment will be made to adjudicate the incident fracture. All study DXA scans will also be evaluated centrally by a blinded independent reviewer. The primary objective of the independent review is to provide objective data to determine the treatment benefit as demonstrated on the pertinent radiologic and clinical data associated with this study.
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Central Review of Radiographs and DXA Scans. All radiographs will be viewed and assessed by a blinded, independent assessor (radiologist) on the basis of existing baseline and study-acquired vertebral deformity, and fracture will be assessed according to a set of pre-determined criteria. A second blinded radiologist will review the assessment of the first reviewer for all patient radiographs in which an incident fracture has been identified. In the case of any disagreement, a third consensus assessment will be made to adjudicate the incident fracture. All study DXA scans will also be evaluated centrally by a blinded independent reviewer. The primary objective of the independent review is to provide an objective, unbiased evaluation of the critical eligibility criteria at screening and during the course of the study to provide objective efficacy data to determine the treatment benefit as demonstrated on the pertinent radiologic and clinical data associated with this study. Finally, all renal CT scans will also be evaluated centrally by a blinded independent reviewer and confirmed by a second reviewer to ensure unbiased assessment of the renal parenchyma and collecting system.
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