{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001","OG002"],"nonInferiorityComment":"The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<.0001","pValueComment":"The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.","statisticalComment":"The level of statistical significance was set at .05 (two-tailed)","statisticalMethod":"Mixed Models Analysis","testedNonInferiority":true},{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001","OG002"],"nonInferiorityComment":"The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":">0.05","pValueComment":"The reported p-value corresponds to the % change from baseline at follow-up in all Arms/groups","statisticalComment":"The level of statistical significance was set at .05 (two-tailed)","statisticalMethod":"Mixed Models Analysis","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.00","value":"0.00"},{"groupId":"OG001","spread":"0.00","value":"0.00"},{"groupId":"OG002","spread":"0.00","value":"0.00"}]}],"title":"baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.14","value":"59.78"},{"groupId":"OG001","spread":"40.72","value":"147.12"},{"groupId":"OG002","spread":"11.54","value":"105.06"}]}],"title":"Day 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"32.24","value":"66.67"},{"groupId":"OG001","spread":"44.45","value":"180.27"},{"groupId":"OG002","spread":"36.80","value":"148.45"}]}],"title":"Day 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.88","value":"71.19"},{"groupId":"OG001","spread":"47.01","value":"167.01"},{"groupId":"OG002","spread":"40.29","value":"165.16"}]}],"title":"Day 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.89","value":"79.39"},{"groupId":"OG001","spread":"25.30","value":"167.27"},{"groupId":"OG002","spread":"47.26","value":"174.58"}]}],"title":"Day 5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.72","value":"74.09"},{"groupId":"OG001","spread":"49.42","value":"239.51"},{"groupId":"OG002","spread":"54.10","value":"230.42"}]}],"title":"Day 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.39","value":"109.27"},{"groupId":"OG001","spread":"65.65","value":"283.15"},{"groupId":"OG002","spread":"104.52","value":"267.89"}]}],"title":"Day 7"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.92","value":"110.61"},{"groupId":"OG001","spread":"93.63","value":"368.31"},{"groupId":"OG002","spread":"78.58","value":"140.58"}]}],"title":"Day 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.53","value":"-35.73"},{"groupId":"OG001","spread":"11.15","value":"-8.60"},{"groupId":"OG002","spread":"20.38","value":"-41.33"}]}],"title":"follow-up"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"% change from baseline","dispersionType":"Standard Error","groups":[{"description":"PTHrP(1-36) 2 picomoles/kg/hr for one week.","id":"OG000","title":"Group 1"},{"description":"PTHrP(1-36) 4 picomoles/kg/hr for one week.","id":"OG001","title":"Group 2"},{"description":"PTHrP(1-36) 5 picomoles/kg/hr for one week.","id":"OG002","title":"Group 3"},{"description":"PTHrP(1-36) 6 picomoles/kg/hr for one week.","id":"OG003","title":"Group 4"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"Baseline, Daily, and 1 week follow-up","title":"Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)","type":"SECONDARY","unitOfMeasure":"% change"}