{"analyses":[{"groupIds":["OG003"],"nonInferiorityType":"OTHER","pValue":"0.007","statisticalMethod":"Mann-Whitney test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.75","value":"0.94"},{"groupId":"OG001","spread":"0.73","value":"0.89"},{"groupId":"OG002","spread":"0.22","value":"0.85"},{"groupId":"OG003","spread":"0.40","value":"0.63"},{"groupId":"OG004","spread":"0.64","value":"1.22"},{"groupId":"OG005","spread":"0.81","value":"1.09"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"15"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"15"}],"units":"Participants"}],"title":"IMWG Responder"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.21","value":"0.95"},{"groupId":"OG001","spread":"0.51","value":"1.18"},{"groupId":"OG002","spread":"0.23","value":"0.98"},{"groupId":"OG003","spread":"0.59","value":"1.15"},{"groupId":"OG004","spread":"0.41","value":"1.18"},{"groupId":"OG005","spread":"1.04","value":"1.51"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"15"},{"groupId":"OG004","value":"15"},{"groupId":"OG005","value":"14"}],"units":"Participants"}],"title":"IMWG Non-Responder"}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"30"},{"groupId":"OG004","value":"31"},{"groupId":"OG005","value":"29"}],"units":"Participants"}],"description":"Secondary Objective 2: To assess whether the novel Magnetic Resonance (MR) protocol and exploratory bone biomarkers can improve detection of longitudinal changes in bone loss in patients with myeloma (new, relapsed, smouldering) and Monoclonal Gammopathy of Undetermined Significance (MGUS) during therapy, compared to Dual-energy X-ray Absorptiometry (DXA) and established bone biomarkers alone.\n\nThis section examined whether longitudinal change in bone turnover markers differed by chemotherapy responders vs non-responders.\n\n* The % change in bone biomarker measurements was expressed as a ratio of follow-up / baseline of paired measurements\n* Participants were classified by International Myeloma Working Group (IMWG) Response Group classification, as responder (partial response, very good partial response or complete response) or non-responder (stable, progressive or relapse).","dispersionType":"Standard Deviation","groups":[{"description":"% Change in measurements of P1NP (Procollagen type 1 N-terminal Propeptide).","id":"OG000","title":"% Change in P1NP"},{"description":"% Change in measurements of CTX-1 (Type I Collagen Cross-Linked C-Telopeptide).","id":"OG001","title":"% Change in CTX-1"},{"description":"% Change in measurements of ALP (Alkaline Phosphatase).","id":"OG002","title":"% Change in ALP"},{"description":"% Change in measurements of DKK1 (Dickkopf WNT Signaling Pathway Inhibitor 1).","id":"OG003","title":"% Change in DKK1"},{"description":"% Change in measurements of sclerostin.","id":"OG004","title":"% Change in Sclerostin"},{"description":"% Change in measurements of the ratio between RANKL and OPG (osteoprotegerin).","id":"OG005","title":"% Change in RANKL:OPG"}],"paramType":"MEAN","populationDescription":"Pooled cohort of participants from Groups 1 and 2 who had a IMWG response classification (responder vs non-responder) and paired serum bone turnover markers measured at baseline and follow-up.","reportingStatus":"POSTED","timeFrame":"Comparison between baseline and follow-up at 6month","title":"Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy (% Change in Bone Turnover Markers)","type":"SECONDARY","unitOfMeasure":"Ratio (follow-up divided by baseline)"}