Osteoporosis and the fractures associated with the condition are a major cause of mortality and morbidity in ageing communities throughout the world, and many drugs for prevention and treatment are under development. Consensus is therefore needed on the principles and methods to be applied in clinical trials of the efficacy and safety of these novel drugs. The guidelines given in this book aim to provide a better understanding of how clinical trials in this field should be conducted. The book describes in detail the studies in laboratory and animal models that must be undertaken before any agent is considered for clinical trial in humans. It goes onto discuss the evidence-based principles underlying Phase I-IV studies, concentrating particularly on Phase III studies in the various types of osteoporosis.
The guidelines are intended to be used by all those who are involved in the development and evaluation of interventions in the management of osteoporosis, including the pharmaceutical industry, drug regulatory authorities, and individual researchers. They offer a practical tool for use by WHO Member States and provide a framework on which national guidelines may be based.