Clinical Trials in Osteoporosis by Colin G. Miller, Derek Pearson (auth.), Dr Derek Pearson

By Colin G. Miller, Derek Pearson (auth.), Dr Derek Pearson BSc, PhD, Dr Colin G. Miller BSc, PhD (eds.)

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Chichester: John Wiley & Sons. 1983. 18. International Conference on Harmonization: Guidance on Statistical Principles for Clinical Trials. Federal Register 1998;63:49583-98. pdt) 19. Kim. JS. Determining Sample Size for Testing Equivalence. Medical Device and Diagnostic Industry. May 1997:114-117. html) Study Design and Endpoints 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 23 Ettinger B, Pressman A, Silver P. Effect of age on reasons for initiation and discontinuation of hormone replacement therapy.

McCloskey EV, Spector TD, Eyres KS et al. The assessment of vertebral deformity: A method for use in population studies and clinical trials. Osteoporos Int 1993;3:138-47. 10. Cook DJ, Guyatt GH, Adachi JD et al. Development and validation of the mini-osteoporosis quality of life questionnaire (OQLQ) in osteoporotic women with back pain due to vertebral fractures. Osteoporosis Quality of Life Study Group. Osteoporos Int 1999;10:207-13. 11. Randell AG, Bhalerao N, Nguyen TV et al. Quality of life in osteoporosis: reliability, consistency, and validity of the Osteoporosis Assessment Questionnaire.

Generally since the radiation dose from a DXA is very low, this is not a significant problem. However, repeat radiographs at the same visit are not acceptable within the current ethical guidelines. The additional radiation dose and the associated risks have to be explained to the patients in simple terms. 1. A typical study flowchart for the sample study used in the book 1 year X X X X 18 months X X 2 years X X X X X 30 months X X X X X X 3 years X X 42 months X X X X X 4 years ~ if ~ o ":i" ~ ::0 Co I» ::0 "" m is "..

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