title: Study design in osteoporosis: a European perspective.
abstract: 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.
authors.affiliation: WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Sheffield, United Kingdom. W.J.Pointefract@sheffield.ac.uk
authors.forename: J A
authors.initials: JA
authors.lastname: Kanis
authors.forename: J M
authors.initials: JM
authors.lastname: Alexandre
authors.forename: H G
authors.initials: HG
authors.lastname: Bone
authors.forename: E
authors.initials: E
authors.lastname: Abadie
authors.forename: D
authors.initials: D
authors.lastname: Brasseur
authors.forename: O
authors.initials: O
authors.lastname: Chassany
authors.forename: S
authors.initials: S
authors.lastname: Durrleman
authors.forename: J F F
authors.initials: JF
authors.lastname: Lekkerkerker
authors.forename: F
authors.initials: F
authors.lastname: Caulin
mesh_terms: D018849:Controlled Clinical Trials as Topic / Q000592:standards; D005060:Europe; D006805:Human Experimentation / Q000592:standards; D006801:Humans; D010024:Osteoporosis / Q000208:ethnology* / Q000628:therapy*; D010919:Placebos / Q000592:standards; D011785:Quality Assurance, Health Care; D012107:Research Design / Q000592:standards*; D018570:Risk Assessment
chemical_list: D010919:Placebos