, Volume 90, Issue 1, pp 1-13

FRAX® with and without Bone Mineral Density

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Abstract

The use of FRAX, particularly in the absence of BMD, has been the subject of some debate and is the focus of this review. The clinical risk factors used in FRAX have high validity as judged from an evidence-based assessment and identify a risk that is responsive to pharmaceutical intervention. Moreover, treatment effects, with the possible exception of alendronate, are not dependent on baseline BMD and strongly suggest that FRAX identifies high-risk patients who respond to pharmaceutical interventions. In addition, the selection of high-risk individuals with FRAX, without knowledge of BMD, preferentially selects for low BMD. The prediction of fractures with the use of clinical risk factors alone in FRAX is comparable to the use of BMD alone to predict fractures and is suitable, therefore, in the many countries where DXA facilities are sparse. In countries where access to BMD is greater, FRAX can be used without BMD in the majority of cases and BMD tests reserved for those close to a probability-based intervention threshold. Whereas the efficacy for agents to reduce fracture risk has not been tested prospectively in randomized controlled trials in patients selected on the basis of FRAX probabilities, there is compelling evidence that FRAX with or without the use of BMD provides a well-validated instrument for targeting patients most likely to benefit from an intervention.

Kanis has received speaker fees, advisory board and/or unrestricted research grants from Abiogen, Italy; Amgen, USA, Switzerland and Belgium; Bayer, Germany; Besins-Iscovesco, France; Biosintetica, Brazil; Boehringer Ingelheim, UK; Celtrix, USA; D3A, France; European Federation of Pharmaceutical Industry and Associations, (EFPIA) Brussels; Gador, Argentina; General Electric, USA; GSK, UK, USA; Hologic, Belgium and USA; Kissei, Japan; Leo Pharma, Denmark; Lilly, USA, Canada, Japan, Australia and UK; Merck Research Labs, USA; Merlin Ventures, UK; MRL, China; Novartis, Switzerland and USA; Novo Nordisk, Denmark; Nycomed, Norway; Ono, UK and Japan; Organon, Holland; Parke-Davis, USA; Pfizer USA; Pharmexa, Denmark; Procter and Gamble, UK, USA; ProStrakan, UK; Roche, Germany, Australia, Switzerland, USA; Rotta Research, Italy; Sanofi-Aventis, USA; Servier, France and UK; Shire, UK; Solvay, France and Germany; Strathmann, Germany; Tarsa Therapeutics, US; Tethys, USA; Teijin, Japan;Teva, Israel; UBS, Belgium; Unigene, USA; Warburg-Pincus, UK; Warner-Chilcott, USA; Wyeth, USA. McCloskey has received speaker fees, advisory board and/or unrestricted research grants from Amgen, Bayer, Hologic, Lilly, Merck, Novartis, Pfizer, Procter & Gamble Pharmaceuticals, Roche, Sanofi-Aventis, Servier and Tethys. Leslie has received speaker fees and unrestricted research grants from Merck Frosst Canada Ltd; unrestricted research grants from Sanofi-Aventis, Procter & Gamble Pharmaceuticals, Novartis, Amgen Pharmaceuticals, Genzyme; advisory boards for Genzyme, Novartis, and Amgen Pharmaceuticals. Johansson and Oden have stated that they have no conflict of interest.