Clinical Trials in Osteoporosis

• Study Design and the Pretrial Phase.- Study Design and Endpoints.- Ethical Considerations.- Standardization and Pretrial Quality Control.- Performing the Trial.- Organization of the Clinical Trial by the Sponsor.- Local Site Organization.- Clinical Trial Quality Assurance.- Laboratory and Instrument Quality Control.- Data Analysis and Presentation.- Data Analysis and Presentation: Writing a Paper for Publication.- Background.- Current Therapies for Osteoporosis.- The Ideal Drug for Treatment of Osteoporosis.- Instrument Measurements in Osteoporosis Clinical Trials: Evaluating the Endpoints.- Biochemical Markers of Bone Turnover.- Future Therapies and Clinical Trials.

From the reviews: This book is a practical bench support for all people involved in clinical research dealing with osteoporosis. The book is well designed, easy to read and easy to address as a reference for all aspects regarding osteoporosis and clinical trials in osteoporosis. The quality control regarding both organizational, technical and clinical aspects up to publication of the results of the trials are thoroughly developed in the book. This book ... does not really have any counterpart in the available literature on the subject. The target audience of the book appears to be very large ... and includes industry partners and sponsors, members of CROs and CRAs and monitors, clinical investigators, physicians and technical staff, clinical trial nurses and other members of the non medical staff involved in a trial related to osteoporosis. (Daniel Uebelhart, Zeitschrift fur Rheumatologie 2003;63(2);208.) This is a practical and well illustrated handbook covering all aspects of clinical trials in the field of osteoporosis. The book is of special interest for everyone planning to conduct research in the specific field of osteporosis. (P. Delince, Acta Orthopaedica Belgica 2005; 71(1),128) From the reviews of the second edition: "A practical manual for clinicians planning and/or participating in trials of osteoporosis treatment. Actually the trials are designed by the manufacturers of the drugs. They also evaluate and usually analyze the data. This book is designed to help the researchers to check whether the protocol is correct and safe. Last but not least, a useful text for pharma." (Zvi Laron, Pediatric Endocrinology Reviews, Vol. 6 (3), March, 2009)