{"classes":[{"categories":[{"measurements":[{"comment":"Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"-0.39"},{"comment":"Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"0.31"},{"comment":"Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"-0.50"},{"comment":"Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"-0.32"},{"comment":"Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"-0.32"},{"comment":"Insufficient number of participants with paired ADC measurements from paired novel MR scans, to enable statistical detection of Spearman's Rank correlation coefficient","groupId":"OG005","lowerLimit":"NA","upperLimit":"NA","value":"-0.14"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"7"},{"groupId":"OG005","value":"7"}],"units":"Participants"}],"title":"% Change in Novel MR ADC"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.42","upperLimit":"0.21","value":"-0.12"},{"groupId":"OG001","lowerLimit":"-0.41","upperLimit":"0.23","value":"-0.10"},{"groupId":"OG002","lowerLimit":"-0.29","upperLimit":"0.33","value":"0.02"},{"groupId":"OG003","lowerLimit":"-0.29","upperLimit":"0.33","value":"0.02"},{"groupId":"OG004","lowerLimit":"-0.08","upperLimit":"0.51","value":"0.24"},{"groupId":"OG005","lowerLimit":"-0.48","upperLimit":"0.16","value":"-0.17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"43"},{"groupId":"OG004","value":"42"},{"groupId":"OG005","value":"38"}],"units":"Participants"}],"title":"% Change in DXA BMD (L1-4)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-0.50","upperLimit":"0.13","value":"-0.20"},{"groupId":"OG001","lowerLimit":"-0.41","upperLimit":"0.24","value":"-0.10"},{"groupId":"OG002","lowerLimit":"-0.47","upperLimit":"0.16","value":"-0.17"},{"groupId":"OG003","lowerLimit":"-0.39","upperLimit":"0.24","value":"-0.09"},{"groupId":"OG004","lowerLimit":"-0.32","upperLimit":"0.32","value":"0.00"},{"groupId":"OG005","lowerLimit":"-0.68","upperLimit":"-0.13","value":"-0.45"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"41"},{"groupId":"OG004","value":"40"},{"groupId":"OG005","value":"36"}],"units":"Participants"}],"title":"% Change in DXA BMD (Femoral Neck)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"43"},{"groupId":"OG004","value":"42"},{"groupId":"OG005","value":"38"}],"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 the correlation (using Spearman's Rank Correlation Coefficient) between longitudinal changes (expressed as a ratio of follow-up / baseline of paired measurements) in bone turnover markers and:\n\n1. Longitudinal changes in DXA Bone Mineral Density (BMD) at lumbar spine (L1-4) and femoral neck;\n2. Longitudinal changes in novel MR Apparent Diffusion Coefficient (ADC) measurements.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"Participants from Groups 1 and 2 were analysed who had a paired bone turnover marker measurements available.\n\nWhere the number analysed for an outcome measure is lower than the overall number of participants analysed, this is due to failure of measurement of either DXA BMD or novel MR ADC, or because ADC measurement was not indicated due to lack of a lytic bone lesion identified on MR.","reportingStatus":"POSTED","timeFrame":"Comparison between baseline and follow-up at 6month","title":"Secondary Outcome 2: Detect Longitudinal Changes in Bone Microarchitecture With Therapy [Correlations Between % Change in Bone Turnover Markers With % Change in Bone Mineral Density (BMD) or Apparent Diffusion Coefficient (ADC)]","type":"SECONDARY","unitOfMeasure":"Spearman's rank correlation coefficient"}