HRT, osteoporosis and regulatory authorities Quis custodiet ipsos custodes?

John C. Stevenson, Martin Birkhäuser, Mark Brincat, Henry Burger, Claus Christiansen, Richard Farmer, J. Christopher Gallagher, Marco Gambacciani, Andrea R. Genazzani, Ulysse J. Gaspard, Peyman Hadji, Peter Kenemans, Michael Kleerekoper, Robert Lindsay, Jo Marsden, Alfred O. Mueck, Santiago Palacios, Amos Pines, Göran Samsioe, Hermann P.G. SchneiderLeon Speroff, John W.W. Studd, David Sturdee, Malcolm I. Whitehead

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Abstract

HRT has been widely used for the relief of menopausal symptoms and the prevention and treatment of post-menopausal osteoporosis. However, following the publication of the Women's Health Initiative (WHI) and the Million Women Study (MWS), regulatory authorities issued an urgent safety restriction on HRT use in preventing post-menopausal osteoporosis, recommending that it now be considered a second-line treatment. Are such recommendations justified? Treatments for osteoporosis, in women with increased future risk for fractures but who have not yet developed the disease, should prevent all types of osteoporotic fractures. Of the available therapies, none other than HRT has been clearly demonstrated to prevent hip fractures in such women. Thus, HRT should be recommended as first-line treatment for osteoporosis prevention. Potential risks of HRT, such as increased development of breast cancer and increased thromboembolism, have long been known. The WHI showed risks in less than 0.3% of women studied, and the MWS appears to have overestimated the risk of breast cancer. Thus, no new safety issues have been identified, and the regulatory authorities may have misinterpreted the data from these recent studies. When given for the correct indications, HRT is of major benefit to many women.

Original languageEnglish (US)
Pages (from-to)1668-1671
Number of pages4
JournalHuman Reproduction
Volume21
Issue number7
DOIs
StatePublished - Jul 2006

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All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Stevenson, J. C., Birkhäuser, M., Brincat, M., Burger, H., Christiansen, C., Farmer, R., Gallagher, J. C., Gambacciani, M., Genazzani, A. R., Gaspard, U. J., Hadji, P., Kenemans, P., Kleerekoper, M., Lindsay, R., Marsden, J., Mueck, A. O., Palacios, S., Pines, A., Samsioe, G., ... Whitehead, M. I. (2006). HRT, osteoporosis and regulatory authorities Quis custodiet ipsos custodes? Human Reproduction, 21(7), 1668-1671. https://doi.org/10.1093/humrep/del043