Is it ethical to use placebos in osteoporosis trials?

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dc.contributor.authorRagi-Eis, Sergio
dc.contributor.authorZerbini, Cristiano Augusto F.
dc.contributor.authorProvenza, Jose R.
dc.contributor.authorGriz, Luiz H. M.
dc.contributor.authorGregorio, Luiz H. de
dc.contributor.authorRusso, Luis A. T.
dc.contributor.authorSilva, Nilzio A.
dc.contributor.authorBorges, Joao L. C.
dc.contributor.authorSouza, Antonio C. A. de
dc.contributor.authorLazaretti-Castro, Marise [UNIFESP]
dc.contributor.authorLewiecki, E. Michael
dc.contributor.institutionOsteoporosis Diag & Res Ctr Espirito Santo
dc.contributor.institutionHosp Heliopolis
dc.contributor.institutionPontificia Univ Catolica Campinas
dc.contributor.institutionUniversidade Federal de Pernambuco (UFPE)
dc.contributor.institutionClin Res Ctr
dc.contributor.institutionUniversidade Federal de Goiás (UFG)
dc.contributor.institutionUniversidade de Brasília (UnB)
dc.contributor.institutionPUC RS
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionNew Mexico Clin Res & Osteoporosis Ctr
dc.date.accessioned2016-01-24T12:41:18Z
dc.date.available2016-01-24T12:41:18Z
dc.date.issued2006-07-01
dc.description.abstractThe use of placebo control groups (e.g., subjects using calcium and vitamin D) in osteoporosis trials with subjects at high risk for fracture has been systematically questioned by institutional review boards (IRBs). Regulatory agencies, on the other hand, continue to not only recommend but also require that placebo-controlled trials be presented for the registration of new drugs for osteoporosis treatment. the Declaration of Helsinki and its updates have upheld the principle that protection of research subjects' rights is of primary concern. Nevertheless, even the Declaration keeps clearly opening the possibility of using placebo-control designs if it is justified for compelling and scientifically sound methodological reasons. the use of intermediary endpoints or surrogates to establish the efficacy or safety of new medications in the management of osteoporosis is currently considered scientifically insufficient. This concept has led regulatory agencies, such as the Food and Drug Administration in the United States and the European Medicines Agency in the European Union, to require fragility fracture reduction as the primary endpoint in clinical trials for the registration of new drugs. Superiority or noninferiority trials are alternatives to placebo-controlled designs. However, factors such as sample size, cost, and statistical limitations render these models impractical for the registration of new medications for osteoporosis. We recommend collaboration among regulatory agencies, IRBs, scientists, and ethicists on the design of clinical trials for the registration of new medications for reduction of fracture risk. Delay in developing mutually acceptable models may impair scientific development in the field and possibly deprive patients of potentially beneficial treatments.en
dc.description.affiliationOsteoporosis Diag & Res Ctr Espirito Santo, BR-29055450 Vitoria, ES, Brazil
dc.description.affiliationHosp Heliopolis, CEPIC, São Paulo, Brazil
dc.description.affiliationPontificia Univ Catolica Campinas, São Paulo, Brazil
dc.description.affiliationUniv Fed Pernambuco, Recife, PE, Brazil
dc.description.affiliationClin Res Ctr, Rio de Janeiro, Brazil
dc.description.affiliationUniv Fed Goias, Fac Med, Goiania, Go, Brazil
dc.description.affiliationUniv Brasilia, BR-70910900 Brasilia, DF, Brazil
dc.description.affiliationPUC RS, Porto Alegre, RS, Brazil
dc.description.affiliationUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.affiliationNew Mexico Clin Res & Osteoporosis Ctr, Albuquerque, NM USA
dc.description.affiliationUnifespUniversidade Federal de São Paulo, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.format.extent274-280
dc.identifierhttp://dx.doi.org/10.1016/j.jocd.2006.04.001
dc.identifier.citationJournal of Clinical Densitometry. New York: Elsevier B.V., v. 9, n. 3, p. 274-280, 2006.
dc.identifier.doi10.1016/j.jocd.2006.04.001
dc.identifier.issn1094-6950
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/29006
dc.identifier.wosWOS:000240321200004
dc.language.isoeng
dc.publisherElsevier B.V.
dc.relation.ispartofJournal of Clinical Densitometry
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.licensehttp://www.elsevier.com/about/open-access/open-access-policies/article-posting-policy
dc.subjectclinical trialsen
dc.subjectcontrolen
dc.subjectdrug studiesen
dc.subjectethicsen
dc.subjectfractureen
dc.subjectosteoporosisen
dc.subjectplaceboen
dc.titleIs it ethical to use placebos in osteoporosis trials?en
dc.typeinfo:eu-repo/semantics/article
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