{"denoms":[{"counts":[{"groupId":"BG000","value":"17"}],"units":"Participants"}],"groups":[{"description":"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.\n\nDexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.\n\nZoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months\n\nBortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles\n\nZoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months\n\nDexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles","id":"BG000","title":"Bortezomib/Dexamethasone/Zoledronic Acid"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"12"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"7"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}],"title":"Greece"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"-3.8","upperLimit":"2.88","value":"-0.29"}]}],"title":"Lumbar spine (L1-L4)"},{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"-3.91","upperLimit":"0.55","value":"-2.83"}]}],"title":"Femoral neck (FN)"}],"description":"Bone Mineral Density of the lumbar spine (L1-L4, anteroposterior view) and femoral neck (FN) was measured by Dual Energy X-Absorptiometry scan (DEXA-scan) using a Hologic QDR-1000 scanner","dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"BMD","unitOfMeasure":"T-score"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0.3","upperLimit":"2.1","value":"0.6"}]}],"title":"CTX"},{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0.1","upperLimit":"14","value":"5.1"}]}],"title":"OC"}],"description":"Bone remodelling was studied by the measurement of the following serum bone metabolism parameters indices using an enzyme-linked immunosorbent assay (ELISA): i) bone resorption marker C-terminal cross-linking telopeptide of collagen type I (CTX) and ii) bone formation marker \\[osteocalcin (OC)\\].","dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Bone remodelling","unitOfMeasure":"ng/ml"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}]}],"description":"Skeletal survey was measured using conventional radiography \\[imaging of the whole skeleton (skull, cervical spine, thoracic spine, lumbar spine, pelvis, humeri, femoral bones)\\].","paramType":"NUMBER","title":"Skeletal survey for osteolytic lesions/fractures","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"3","upperLimit":"10","value":"5"}]}]}],"description":"Bone pain was measured with the use of the Visual Analogue Scale. The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.\n\nThe VAS for Bone Pain was constructed as follows:\n\nNone Mild Moderate Severe Worst possible 1,2 3,4 5,6 7,8 9,10 Lower values are considered to be of a better outcome, higher values are considered to be of a worst outcome.","dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Bone pain","unitOfMeasure":"units on a scale"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"4.5","upperLimit":"34","value":"15.8"}]}]}],"description":"Bone remodelling was studied by the measurement of the following serum bone metabolism parameters indices using an enzyme-linked immunosorbent assay (ELISA) bone formation marker \\[bone-specific alkaline phosphatase (bALP)\\].","dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Bone remodelling","unitOfMeasure":"U/L"}]}