Statement in response to recent BMJ paper by Järvinen et al.
June 19, 2015, Bristol, UK. Press Dispensary. The European Calcified Tissue Society (ECTS) has issued a statement in response to the recent paper by Järvinen et al. in the BMJ (1). As a scientific organization promoting research to improve bone health, we wish to make the following comments to this paper, which we find just adds to the confusion amongst patients with biased citations and unsubstantiated statements.
The authors are of the opinion that stopping smoking, eating healthy food and exercising will take care of the problem more effectively, but fail to produce the evidence that such public health approaches really have shown superiority over pharmacological therapy in the long term. Where is the evidence that such measures would be more cost-effective, and what would be the long-term adherence to such measures among elderly frail individuals?
The authors also ignore that a hip fracture is the last stage in a cascade involving forearm fractures and vertebral fractures, where the latter also has shown significant mortality of some 30% within one year. With the most effective antiresorptive drugs the number needed to treat to avoid one vertebral fracture employing the commonly agreed criteria for identification of individuals at risk is 9. This is much lower than numbers for interventions like antihypertensives to prevent an ischemic stroke. By looking at hip fractures in isolation the authors leave out the effect of treatment on other important consequences of osteoporosis; for example vertebral fractures, pelvic fractures and forearm fractures. This corresponds to only considering the effect of antihypertensives on myocardial infarction, without acknowledging additional beneficial effects on, for example, strokes and peripheral arteriosclerosis.
The authors state that prevention of falls is not employed to avoid hip fracture. All osteoporosis guidelines worldwide emphasize prevention of falls and “fall clinics” are widespread. But this does not rule out to further reduce risk by strengthening bone in individuals at risk. Ignoring pharmacotherapy would be analogous to withholding statins in individuals at risk for CV disease, where weight loss and smoking cessation are important non-pharmacologic measures. The authors use the study by Greenspan et al. (2) to prove that drug treatment of hip fractures is ineffective, but this study, comprising only 181 women, was severely underpowered to look at fractures.
The cost effectiveness of pharmacological interventions in patients at risk of hip fracture has clearly been demonstrated in analyses of fracture liaison approaches to treatment of osteoporosis. Moreover, most countries are employing cost effectiveness analyses to determine whether new drugs should be approved. In this context, hip fractures have the biggest impact due to their severe economic consequences.
The authors cite atypical femoral fractures (AFF) after antiresorptive drug treatment as a major concern, despite the fact that numerous analyses have demonstrated that the risk benefit ratio vs. number of hip fractures prevented is still way in favor of continued antiresorptive treatment. The 3 studies on AFF where X-ray based diagnosis was performed cite incidence rates between 0,3-5/10,000 (3). The risk of GI bleeds associated with NSAIDS is 100 fold higher (4).
The authors do not mention at all that osteoporosis treatment after hip fracture reduces all cause mortality by around 30%. This should be taken into account when considering the risk to benefit ratio of osteoporosis treatment.
While we agree with Järvinen et al. that other preventive measures apart from drug treatment should be employed when treating hip fractures, we strongly regret the potential negative impact of this manuscript on effective prevention of osteoporotic fractures and the well-demonstrated effects of such treatments on morbidity, mortality and health care costs.
1. Jarvinen TL, Michaelsson K, Jokihaara J, Collins GS, Perry TL, Mintzes B, et al. Overdiagnosis of bone fragility in the quest to prevent hip fracture. Bmj. 2015;350:h2088.
2. Greenspan SL, Perera S, Ferchak MA, Nace DA, Resnick NM. Efficacy and safety of single-dose zoledronic acid for osteoporosis in frail elderly women: a randomized clinical trial. . JAMA internal medicine. 2015;ePub.
3. Schilcher J, Michaelsson K, Aspenberg P. Bisphosphonate use and atypical fractures of the femoral shaft. NEnglJMed. 2011;364(18):1728-37.
4. Hernandez-Diaz S, Garcia-Rodriguez LA. Epidemiologic assessment of the safety of conventional nonsteroidal anti-inflammatory drugs. The American journal of medicine. 2001;110 Suppl 3A:20S-7S.
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For further information please contact
Roberta Mugnai, ECTS executive director
European Calcified Tissue Society (ECTS)
Tel: + 32 476 520 716