OSTEOPOROSIS CLINICAL-TRIALS END-POINTS - CANDIDATE VARIABLES AND CLINIMETRIC PROPERTIES

We reviewed evidence on endpoints used in osteoporosis clinical trials to assist in the development of a set of endpoints to be included in all trials. A MEDLINE search was conducted using the Cochrane Collabor ation strategy for each endpoint. Additional published literature was obtained from content experts. A proposed list of endpoints was develo ped after consultation with experts in the field. Each endpoint was ev aluated with respect to validity, reproducibility, redundancy, and fea sibility. We classified the endpoints into 2 major categories: clinica l health status outcomes and intermediate endpoints, and for each endp oint we present current evidence from the literature as pertains to de fined methodologic criteria. Multiple endpoints have been used in oste oporosis clinical trials, and an agreement on a core set of measures n eeds to be evidence based with an emphasis on validity, reproducibilit y, and feasibility and to satisfy clinical credibility.