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Study Design in Osteoporosis: A European Perspective
Author(s) -
Kanis Ja,
Alexandre JM,
Bone Hg,
Abadie E,
Brasseur D,
Chassany O,
Durrleman S,
Lekkerkerker Jff,
Caulin F
Publication year - 2003
Publication title -
journal of bone and mineral research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.882
H-Index - 241
eISSN - 1523-4681
pISSN - 0884-0431
DOI - 10.1359/jbmr.2003.18.6.1133
Subject(s) - osteoporosis , placebo , medicine , equivalence (formal languages) , clinical trial , perspective (graphical) , physical therapy , alternative medicine , computer science , mathematics , pathology , artificial intelligence , discrete mathematics
The advent of effective agents for the treatment of osteoporosis has led to the view that placebo‐controlled trials to test new agents for efficacy are no longer appropriate. Rather, studies of superiority, equivalence, or non‐inferiority have been recommended. Such studies require very large sample sizes, and the burden of osteoporotic fracture in a trial setting is substantially increased. Studies of equivalence cannot be unambiguously interpreted because the variance in effect of active comparator agents is too large in osteoporosis. If fracture studies are required by regulatory agencies, there is still a requirement for placebo‐controlled studies, although perhaps of shorter duration than demanded at present.