Giáo trình Y Dược: Clinical Trials in Osteoporosis Second Edition (Những Thử nghiệm lâm sàng trong Bệnh loãng xương - Bản 2)

DEREK PEARSON - COLIN MILLER

CLINICAL TRIALS IN OSTEOPOROSIS SECOND EDITION

(NHỮNG THỬ NGHIỆM LÂM SÀNG TRONG BỆNH LOÃNG XƯƠNG - BẢN 2)

PUBLISHER: SPRINGER-VERLAG (LONDON, UK - 2007)

THÔNG TIN CHUNG:

Tiêu đề: Clinical Trials in Osteoporosis Second Edition (tạm dịch: Những Thử nghiệm lâm sàng trong Bệnh loãng xương - Bản 2).

Tác giả: Derek Pearson - Colin Miller.

NXB: Springer-Verlag (2007).

Thông số: 294 trang - 4 phần, 14 chương chính.

Bệnh loãng xương là tình trạng suy giảm về khối lượng và mật độ xương. Bệnh đặc biệt hay được phát hiện ở người có tuổi. Loãng xương được coi là kẻ giết người thầm lặng bởi quá trình dẫn tới loãng xương là 1 quá trình kéo dài, hầu như xảy ra với tất cả mọi người bắt đầu từ sau tuổi 30, nhưng gần như rất ít biểu hiện, khiến mọi người thường chủ quan. Cuốn sách này sẽ cung cấp những thử nghiệm tiên tiến nhất trong chẩn đoán và điều trị bệnh loãng xương thông qua các phương pháp chuyên môn của hóa sinh - y học. Hy vọng cuốn sách sẽ đem đến cho quý độc giả nhiều thông tin và kiến thức giá trị!

INTRODUCTION (GIỚI THIỆU):

There have been many books published about the design, conduct, and analysis of clinical trials. Why are osteoporosis trials a special case that deserve a book of their own? There are three main reasons. First, most diseases have a well-understood definition and aetiology. Osteoporosis is a disease that is understood by those work-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 treatments for the so-called “silent epidemic”.

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 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 predisposing to an increased risk of fracture.” The World Health Organization (WHO) operationally defines osteoporosis as “bone density 2.5 standard devia-tions (SDs) below the mean for young white adult women at lumbar spine, femoral neck, or forearm”. It is now recommended that the diagnostic use of this definition is restricted to bone density of the femur.4 Although it is not clear how to apply this in men and children, it is recommended that the same diagnostic thresholds can be used in men.

TABLE OF CONTENTS (MỤC LỤC):

Foreword to the First Edition

Contributors

Contributor

Biographies

1 Introduction

Section 1 Study Design and the Pretrial Phase

2 Study Design and Endpoints

3 Ethical Considerations

4 Standardization and Pretrial Quality Control

Section 2 Performing the Trial

5 Organization of the Clinical Trial by the Sponsor

6 Local Site Organization

7 Clinical Trial Quality Assurance

8 Laboratory and Instrument Quality Control

Section 3 Data Analysis and Presentation

9 Data Analysis and Presentation: Writing a Paper for Publication

Section 4 Background

10 Current Therapies for Osteoporosis

11 The Ideal Drug for Treatment of Osteoporosis

12 Instrument Measurements in Osteoporosis

13 Biochemical Markers of Bone Turnover

14 Future Therapies and Clinical Trials

Appendix A: Glossary

Appendix B: Sample Data from the Example Study Used in this Book

Index

Download Ebook: CLINICAL TRIALS IN OSTEOPOROSIS SECOND EDITION

========================