[Evaluation of the treatment and efficacy of osteoporosis]

1. General concept of the treatment: The aim of the treatment based on the improvement in Activation-Resorption-Formation bone remodeling sequence. II. Method of efficacy evaluation: To prove the efficacy of the drug, it is necessary to determine the primary endpoints before starting clinical trials. Reduction of fracture rate in the patients with osteoporosis is expected as a target endpoint. Improvement in biomechanical tests of bone strength is also taken into consideration. Improvement in bone mineral density could be a surrogate endpoint, however, the benefit in "pain" is taken only as "for reference". Among the measurement of bone mineral density, DEXA is becoming a better tool. We can also use the parameters of biochemical markers of bone turnover, as a surrogate endpoint.