EMEA guidelines for trials in osteoporosis: design implications.
The design, execution and interpretation of trials that do not contain a placebo arm are a challenge. These issues are briefly discussed in the context of the new European guidelines for the study of drugs for the indication prevention and treatment of postmenopausal osteoporosis.
Boers
M
M
Department of Clinical Epidemiology & Biostatistics, Free University Hospital, PO Box 7057, 1007 MB Amsterdam, The Netherlands.
D015519:Bone Density; D002986:Clinical Trials as Topic; D005060:Europe; D005260:Female; D005598:Fractures, Spontaneous / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D012107:Research Design; D018401:Sample Size