Clinical Trials in Osteoporosis

COLING. MILLER ANDDEREKPEARSON 1. 1. Why a Book about Clinical Trials in Osteoporosis? There have been many books published about the design, conduct, and analysis of clinicaltrials. Whyareosteoporosistrialsaspecialcasethatdeserveabookoftheir own? There are three main reasons. First, most diseases have a well-understood definitionandaetiology. Osteoporosisisadiseasethatisunderstoodbythosewo- ing within the subspecialty, but currently there is no definition that is agreeable to both medical and scientific communities and its aetiology is poorly understood. It is within this framework that the pharmaceutical industry is trying to develop new treatmentsfortheso-called"silentepidemic". In layman's terms, the disease of osteoporosis is defined as "brittle bones occurring in the elderly that could lead to fractures. "The classical definition was "a bony fracture caused by minimal trauma owing to a loss in bone mineral. " A published consensus definition states that osteoporosis is "a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to 1 fractures. " The National Institutes of Health (NIH) Consensus Conference Statement on Osteoporosis Prevention, Diagnosis, and Therapy states that "osteoporosis is a skeletal disorder characterized by compromised bone strength 2 predisposing to an increased risk of fracture. " The World Health Organization (WHO) operationally defines osteoporosis as "bone density 2. 5 standard dev- tions (SDs) below the mean for young white adult women at lumbar spine, 3 femoralneck,orforearm". Itisnowrecommendedthatthediagnosticuseofthis 4 definition is restricted to bone density of the femur.

List of contents

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.

Summary

COLING. MILLER ANDDEREKPEARSON 1. 1. Why a Book about Clinical Trials in Osteoporosis? There have been many books published about the design, conduct, and analysis of clinicaltrials. Whyareosteoporosistrialsaspecialcasethatdeserveabookoftheir own? There are three main reasons. First, most diseases have a well-understood definitionandaetiology. Osteoporosisisadiseasethatisunderstoodbythosewo- ing within the subspecialty, but currently there is no definition that is agreeable to both medical and scientific communities and its aetiology is poorly understood. It is within this framework that the pharmaceutical industry is trying to develop new treatmentsfortheso-called“silentepidemic”. In layman’s terms, the disease of osteoporosis is defined as “brittle bones occurring in the elderly that could lead to fractures. ”The classical definition was “a bony fracture caused by minimal trauma owing to a loss in bone mineral. ” A published consensus definition states that osteoporosis is “a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to 1 fractures. ” The National Institutes of Health (NIH) Consensus Conference Statement on Osteoporosis Prevention, Diagnosis, and Therapy states that “osteoporosis is a skeletal disorder characterized by compromised bone strength 2 predisposing to an increased risk of fracture. ” The World Health Organization (WHO) operationally defines osteoporosis as “bone density 2. 5 standard dev- tions (SDs) below the mean for young white adult women at lumbar spine, 3 femoralneck,orforearm”. Itisnowrecommendedthatthediagnosticuseofthis 4 definition is restricted to bone density of the femur.

Additional text

From the reviews:

<sup>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 für 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. Delincé, 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)</sup>

Report

From the reviews:
<sup>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 für 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. Delincé, 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)</sup>

Product details

• Authors: Derek Pearson
• Assisted by: G Miller (Editor), G Miller (Editor), Colin Miller (Editor), Colin G. Miller (Editor), Dere Pearson (Editor), Derek Pearson (Editor), Derek E. Pearson (Editor)
• Publisher: Springer, Berlin
• Languages: English
• Product format: Paperback / Softback
• Released: 13.03.2002
• EAN: 9781846283895
• ISBN: 978-1-84628-389-5
• No. of pages: 292
• Weight: 506 g
• Illustrations: X, 292 p. 50 illus.
• Series: Clinical Trials; Clinical Trials
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Clinical medicine; A, Medicine, Orthopedics, INTERNAL MEDICINE, Orthopaedics, Pharmacology, Rheumatology, Pharmacology/Toxicology