Is it ethical to use placebos in osteoporosis trials?

Is it ethical to use placebos in osteoporosis trials?

Author Ragi-Eis, Sergio Google Scholar
Zerbini, Cristiano Augusto F. Google Scholar
Provenza, Jose R. Google Scholar
Griz, Luiz H. M. Google Scholar
Gregorio, Luiz H. de Google Scholar
Russo, Luis A. T. Google Scholar
Silva, Nilzio A. Google Scholar
Borges, Joao L. C. Google Scholar
Souza, Antonio C. A. de Google Scholar
Lazaretti-Castro, Marise Autor UNIFESP Google Scholar
Lewiecki, E. Michael Google Scholar
Institution Osteoporosis Diag & Res Ctr Espirito Santo
Hosp Heliopolis
Pontificia Univ Catolica Campinas
Universidade Federal de Pernambuco (UFPE)
Clin Res Ctr
Universidade Federal de Goiás (UFG)
Universidade de Brasília (UnB)
PUC RS
Universidade Federal de São Paulo (UNIFESP)
New Mexico Clin Res & Osteoporosis Ctr
Abstract The 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.
Keywords clinical trials
control
drug studies
ethics
fracture
osteoporosis
placebo
Language English
Date 2006-07-01
Published in Journal of Clinical Densitometry. New York: Elsevier B.V., v. 9, n. 3, p. 274-280, 2006.
ISSN 1094-6950 (Sherpa/Romeo, impact factor)
Publisher Elsevier B.V.
Extent 274-280
Origin http://dx.doi.org/10.1016/j.jocd.2006.04.001
Access rights Closed access
Type Article
Web of Science ID WOS:000240321200004
URI http://repositorio.unifesp.br/handle/11600/29006

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