Instrument Measurements in Osteoporosis Clinical Trials: Evaluating the Endpoints
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).
KeywordsVertebral Fracture Vertebral Deformity Vertebral Fracture Assessment Fracture Intervention Trial Spine Deformity Index
Unable to display preview. Download preview PDF.
- 2.Notes for Guidance on Postmenopausal Osteoporosis in Women. CPMP, 2001 (http://www.emea.eu.int/pdfs/human/ewp/055295en.pdf).
- 8.Cawte SA. Morphometric X-ray absorptiometry using the Hologic QDR 2000. MPhil Thesis, University of Nottingham, 1999.Google Scholar
- 10.National Osteoporosis Foundation Working Group on Vertebral Fractures. Report Assessing Vertebral Fractures. J Bone Miner Res 1995; 10: 518–22.Google Scholar
- 11.Genant HK, Jergas M, van Kuijk C. Vertebral Fractures in Osteoporosis. San Fransisco: Radiology Research Education Foundation, 1995.Google Scholar
- 13.Jergas M, Genant HK, Nevitt MC. Standardized visual assessment of osteoporotic vertebral deformities. In: Genant HK, Jergas M, van Kuijk C. Vertebral Fractures in Osteoporosis. San Francisco: Radiology Research Education Foundation, pp 149–61, 1995.Google Scholar