Instrument Measurements in Osteoporosis Clinical Trials: Evaluating the Endpoints

  • Colin G. Miller


Medical instruments can be used in one of four primary ways: for screening, diagnosis and or prognosis, monitoring the natural history of the disease or therapeutic intervention. Good quantitative endpoints in clinical trials are usually obtained from instruments measuring a physiological parameter that is relevant to the anticipated effect of the molecular entity under investigation, and nowhere is this more apparent than in the field of osteoporosis. The surrogate endpoint of choice, BMD, is in fact a recognized diagnostic endpoint in its own right, with the World Health Organization (WHO) criterion defining an individual with a BMD that is more than 2.5 SD below peak bone mass as osteoporotic. However, in the arena of clinical trials it is not quite as simple as this (see section on endpoints in Chapter 2).


Vertebral Fracture Vertebral Deformity Vertebral Fracture Assessment Fracture Intervention Trial Spine Deformity Index 
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© Springer-Verlag London 2002

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  • Colin G. Miller

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