{"analyses":[{"ciLowerLimit":"0.34","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.84","estimateComment":"Values \\< 1 for odds ratio favor denosumab.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0070","paramType":"Odds Ratio (OR)","paramValue":"0.54","statisticalComment":"Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"31"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"809"},{"groupId":"OG001","value":"835"}],"units":"Participants"}],"description":"Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height.\n\nA new vertebral fracture was defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. Worsening of pre-existing fractures was defined as an increase in fracture severity of at least 1 grade on the semiquantitative scale.","groups":[{"description":"Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.","id":"OG000","title":"Placebo"},{"description":"Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.","id":"OG001","title":"Denosumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Vertebral Fracture Analysis Set: all participants with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36","reportingStatus":"POSTED","timeFrame":"36 months","title":"Number of Participants With New or Worsening Vertebral Fractures","type":"SECONDARY","unitOfMeasure":"Participants"}