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Technical Report Series, No. 843
1994, v + 129 pages [C*, E, F, R, S]
ISBN 92 4 120843 0
Sw.fr. 22./US $19.80; in developing countries: Sw.fr. 15.40
Order no. 1100843
An expert technical assessment of the many factors that influence the risk of osteoporotic fracture in postmenopausal women and thus need to be considered when planning the most effective public health interventions. In view of growing awareness of the need to prevent and treat postmenopausal osteoporosis, the book aims to resolve several controversies concerning the usefulness of screening programmes, the appropriate target populations, the most effective methods for predicting fracture risk, techniques for assessment, and the comparative effectiveness of currently available preventive and therapeutic interventions.
A large part of the report is devoted to a review of the advantages and limitations of three candidate methods for predicting future fracture risk: assessment of bone mass, assessment of bone loss, and clinical assessment of risk factors. Information on non-invasive physical techniques for bone mass assessment is especially detailed. A section devoted to the risks and benefits of intervention evaluates the efficacy and safety of hormone replacement therapy, using estrogens alone or estrogens combined with progestogens, and other currently available interventions, including the use of calcium, calcitonins, and bisphosphonates. Particular attention is given to the assessment of evidence that estrogen replacement therapy might increase the risk of certain cancers and decrease the risk of morbidity and mortality from cardiovascular disease. The final section reaches several important conclusions about the aims and design of screening programmes.
Guidelines for Preclinical Evaluation and Clinical Trials in Osteoporosis
1998, vi + 68 pages
ISBN 92 4 154522 4
Swiss francs 23.-/US $20.70; in developing countries: Swiss francs 16.10
Order no. 1150435
This book provides comprehensive guidelines for the design, implementation, and interpretation of preclinical studies and clinical trials of agents undergoing investigation for the management of osteoporosis. Noting the magnitude of the public health problem caused by osteoporosis and related fractures, the book responds to the urgent need for a cohesive and rational approach to the search for new therapeutic or preventive agents. Recommended principles and methods reflect the consensus reached by a large number of international experts, representatives of the pharmaceutical industry, and drug regulatory authorities.
The book opens with a brief discussion of the current and future public health problem caused by osteoporotic fractures, followed by conceptual and operational definitions of osteoporosis and a recommended classification of four intervention categories that facilitate the definition of treatment objectives and the design of targetted studies.
Against this background, the next chapter offers a detailed guide to the aims, design, conduct and interpretation of preclinical studies. Specific recommendations are given for the selection of in vitro and animal models, the design of the study, including dose ranges and duration of treatment, and the most appropriate end-points for assessing efficacy.
The most extensive chapter provides a comprehensive description of basic principles and methods to follow during clinical trials. Information ranges from a discussion of problems with the use of bone mineral density to predict fracture risk, through advice on the choice of tests and techniques for measuring the effects of interventions, to a discussion of general principles of trial design, including selection of study population, treatment regimen, duration of studies, sample size, and frequency of measurement. Drawing on these detailed principles and methods, subsequent chapters offer concise guidance specific to phase I and phase II studies, phase III studies in severe osteoporosis, phase III studies in osteoporosis without fragility fractures, and phase III studies in osteopenia. The book concludes with chapters outlining principles and methods for phase III clinical trials in subjects with normal bone mass, and for phase IV studies.
Research on the Menopause in the 1990s
Report of a WHO Scientific Group
WHO Technical Report Series, No. 866
1996, vii + 106 pages [E, F*, S*]
ISBN 92 4 120866 X
Sw.fr. 20.-/US $18.00; in developing countries: Sw.fr. 14.-
Order no. 1100866
An expert assessment of what is known about the menopause, its immediate and long-term effects on health, and the possibilities for their treatment and prevention. Noting the many methodological problems surrounding research on the menopause, the report makes a special effort to separate those areas where firm conclusions can be reached from those where questions remain and further research is needed. Particular attention is given to the risks and benefits of hormone therapy.
The report has twelve sections. Methodological problems are addressed in the first, which considers the strengths and weaknesses of various investigative approaches and explains why certain designs are more likely to yield reliable results. Subsequent sections review the demography of the menopause and summarize what is known about the endocrinology of the normal menopause. A section on symptoms and their treatment underscores the importance of distinguishing between symptoms that result from loss of ovarian function and symptoms that arise from the ageing process or from the socio-environmental stress of the mid-life years.
The most extensive sections attempt to resolve some of the controversy surrounding the use of hormone therapy to reduce the risks of osteoporotic fractures and cardiovascular diseases while also answering the question of whether hormone therapy increases the risk of breast cancer, endometrial cancer, and other gynaecological cancers. Information ranges from advice on calcium and vitamin D supplementation for the prevention of osteoporosis, to estimates of the increase in relative risk of breast cancer among women using estrogens alone for different lengths of time.
The report concludes with a balanced discussion of strategies for managing the health consequences of the menopause, emphasizing the need for a clear distinction between short-term therapeutic and long-term preventive goals, since the risks and benefits of the two types of therapy are very different.