[Efficacy and safety assessments of pharmaceutical agents].
There have been several clinical end-points available for efficacy assessments of pharmaceutical agents for osteoporosis in clinical trials. In such trials with alendronate and risedronate, new generation of bisphosphonates, either bone mass measurements or incidental fractures assessments are primary end-points. Markers for bone turnover are frequently measured in trials with protocols for dose finding and action mechanisms of agents. Bone biopsy and bone histomorphometry are needed for assessments of long-term safety. Therefore, multiple clinical trials should be completed to establish efficacy and safety of bisphosphonates.
Nakatsuka
K
K
Second Department of Internal Medicine, Osaka City University Medical School.