[Bone and Calcium Update ; Diagnosis and therapy of metabolic bone disease update. Advances in clinical trials for osteoporosis in Japan].
Author(s): Nakamura T
Affiliation(s): Department of Orthopedics, School of Medicine, University of Occupational and Environmental Health, Japan.
Publication date & source: 2011-12, Clin Calcium., 21(12):1895-901.
Publication type: English Abstract
Microdensitometry of the metacarpal bone on radiograph was first set up as the endpoint of the treatment in clinical trials in Japan in 1980s. Then, radial bone mineral content obtained by single photon absorptiometry was used. In 1990s, lumbar spine BMD measured by DXA became the major endpoint of the study which was designed as prospective, randomized, double-blind, controlled trial. In 2000s, assessments on the incidences of the vertebral fractures have become mandatory as the primary endpoint of the placebo-controlled trial. The numbers of the subjects required in the study are getting larger and the subtleties in the study including adverse events more important along the progress of evidence-based medicine.