{"analyses":[{"ciLowerLimit":"-0.01","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.01","estimateComment":"luspatercept - placebo","groupDescription":"Total Hip Bone Mineral Density: Change from baseline at Week 48 LS = least squares","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.9201","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"LS Mean of Difference","paramValue":"0.00","statisticalComment":"Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.","statisticalMethod":"ANCOVA"},{"ciLowerLimit":"-0.02","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.01","estimateComment":"luspatercept - placebo","groupDescription":"Lumbar Spine Bone Mineral Density: Change from baseline at Week 48 LS = least squares","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4620","pValueComment":"Significance level of 0.050 for 2-sided tests.","paramType":"LS Mean of Difference","paramValue":"-0.01","statisticalComment":"Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.","statisticalMethod":"ANCOVA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.050","value":"0.01"},{"groupId":"OG001","spread":"0.057","value":"0.01"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"190"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"title":"Total Hip"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.063","value":"-0.00"},{"groupId":"OG001","spread":"0.078","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"189"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"title":"Lumbar Spine"}],"denoms":[{"counts":[{"groupId":"OG000","value":"190"},{"groupId":"OG001","value":"97"}],"units":"Participants"}],"description":"For BMD, the lumbar spine and total hip were measured at baseline and 48 weeks by dual energy x-ray absorptiometry (DXA). Baseline was defined as the last value on or before the first dose of study drug is administered; if multiple values are present for the same date, the average of these values was used. If during the 48 week double-blinded treatment period, a participant has only one assessment, it is counted as 'Week 48' visit; if a participant has multiple assessments, the last one is used as 'Week 48' visit. The analysis was done on the population that had at least 2 measurements.","dispersionType":"Standard Deviation","groups":[{"description":"Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care","id":"OG000","title":"Luspatercept + BSC"},{"description":"Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care","id":"OG001","title":"Placebo + BSC"}],"paramType":"MEAN","populationDescription":"All randomized participants with available measurements at the specified timepoints","reportingStatus":"POSTED","timeFrame":"Baseline: Day 1; Treatment: Week 48","title":"Mean Change From Baseline In Total Hip And Lumbar Spine Bone Mineral Density (BMD) At Week 48","type":"SECONDARY","unitOfMeasure":"gm/cm^2"}