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Clinical Trials in Osteoporosis

  • Book
  • © 2007

Overview

Editors:
  1. Derek Pearson

    1. Medical Physics & Clinical Engineering Department, Nottingham University Hospitals NHS Trust, Nottingham, UK

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    You can also search for this editor in PubMed   Google Scholar

  2. Colin G. Miller

    1. Medical Affairs, Bio-Imaging Technologies Inc., Newtown, USA

    View editor publications

    You can also search for this editor in PubMed   Google Scholar

  • A practical manual for clinicians/scientists coming to the subject new - provides a standard for existing centers to measure themselves against
  • Specifically addresses clinical trials in osteoporosis (no such other book is in the Library of Congress Catalog)
  • Combines a number of issues brought together for the first time
  • Uniquely written both from the viewpoint of the technologist and the MD investigator as well as the pharmaceutical personnel
  • In-depth coverage of Good Clinical Practice (GCP)

Part of the book series: Clinical Trials (CLINICAL)

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Table of contents (14 chapters)

  1. Front Matter

    Pages i-xiii
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  2. Introduction

    1. Introduction

      • Colin G. Miller, Derek Pearson
      Pages 1-4

  3. Study Design and the Pretrial Phase

    1. Front Matter

      Pages 5-5
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    2. Study Design and Endpoints

      • Derek Pearson, Colin G. Miller
      Pages 7-25

    3. Ethical Considerations

      • Derek Pearson, Colin G. Miller
      Pages 27-46

    4. Standardization and Pretrial Quality Control

      • Derek Pearson
      Pages 47-72

  4. Performing the Trial

    1. Front Matter

      Pages 73-73
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    2. Organization of the Clinical Trial by the Sponsor

      • Colin G. Miller
      Pages 75-89

    3. Local Site Organization

      • Dorothy Adams, Colin G. Miller
      Pages 91-102

    4. Clinical Trial Quality Assurance

      • Susan A. Earnshaw
      Pages 103-140

    5. Laboratory and Instrument Quality Control

      • Derek Pearson, Nigel Lawson
      Pages 141-159

  5. Data Analysis and Presentation

    1. Front Matter

      Pages 161-161
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    2. Data Analysis and Presentation: Writing a Paper for Publication

      • Derek Pearson
      Pages 163-186

  6. Background

    1. Front Matter

      Pages 187-187
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    2. Current Therapies for Osteoporosis

      • Jonathan R. Bayly
      Pages 189-210

    3. The Ideal Drug for Treatment of Osteoporosis

      • David J. Hosking
      Pages 211-233

    4. Instrument Measurements in Osteoporosis Clinical Trials: Evaluating the Endpoints

      • Colin G. Miller
      Pages 235-246

    5. Biochemical Markers of Bone Turnover

      • Penny Blackwell, Ian M. Godber, Nigel Lawson
      Pages 247-269

    6. Future Therapies and Clinical Trials

      • Colin G. Miller
      Pages 271-278

  7. Back Matter

    Pages 279-292
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Keywords

About this book

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.

Reviews

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 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)

Editors and Affiliations

  • Medical Physics & Clinical Engineering Department, Nottingham University Hospitals NHS Trust, Nottingham, UK

    Derek Pearson

  • Medical Affairs, Bio-Imaging Technologies Inc., Newtown, USA

    Colin G. Miller

Bibliographic Information

  • Book Title: Clinical Trials in Osteoporosis

  • Editors: Derek Pearson, Colin G. Miller

  • Series Title: Clinical Trials

  • DOI: https://doi.org/10.1007/978-1-84628-587-5

  • Publisher: Springer London

  • eBook Packages: Medicine, Medicine (R0)

  • Copyright Information: Springer-Verlag London 2007

  • Softcover ISBN: 978-1-84628-389-5Published: 19 April 2007

  • eBook ISBN: 978-1-84628-587-5Published: 27 May 2007

  • Edition Number: 2

  • Number of Pages: X, 292

  • Number of Illustrations: 50 b/w illustrations

  • Topics: Orthopedics, Rheumatology, Pharmacology/Toxicology

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