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      The Emperor's New Clothes : What Randomized Controlled Trials Don't Cover : WHAT RANDOMIZED CONTROLLED TRIALS DON'T COVER

      1 , 2 , 3
      Journal of Bone and Mineral Research
      Wiley

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          Atypical subtrochanteric and diaphyseal femoral fractures: second report of a task force of the American Society for Bone and Mineral Research.

          Bisphosphonates (BPs) and denosumab reduce the risk of spine and nonspine fractures. Atypical femur fractures (AFFs) located in the subtrochanteric region and diaphysis of the femur have been reported in patients taking BPs and in patients on denosumab, but they also occur in patients with no exposure to these drugs. In this report, we review studies on the epidemiology, pathogenesis, and medical management of AFFs, published since 2010. This newer evidence suggests that AFFs are stress or insufficiency fractures. The original case definition was revised to highlight radiographic features that distinguish AFFs from ordinary osteoporotic femoral diaphyseal fractures and to provide guidance on the importance of their transverse orientation. The requirement that fractures be noncomminuted was relaxed to include minimal comminution. The periosteal stress reaction at the fracture site was changed from a minor to a major feature. The association with specific diseases and drug exposures was removed from the minor features, because it was considered that these associations should be sought rather than be included in the case definition. Studies with radiographic review consistently report significant associations between AFFs and BP use, although the strength of associations and magnitude of effect vary. Although the relative risk of patients with AFFs taking BPs is high, the absolute risk of AFFs in patients on BPs is low, ranging from 3.2 to 50 cases per 100,000 person-years. However, long-term use may be associated with higher risk (∼100 per 100,000 person-years). BPs localize in areas that are developing stress fractures; suppression of targeted intracortical remodeling at the site of an AFF could impair the processes by which stress fractures normally heal. When BPs are stopped, risk of an AFF may decline. Lower limb geometry and Asian ethnicity may contribute to the risk of AFFs. There is inconsistent evidence that teriparatide may advance healing of AFFs.
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              Incidence of atypical nontraumatic diaphyseal fractures of the femur.

              Bisphosphonates reduce the rate of osteoporotic fractures in clinical trials and community practice. "Atypical" nontraumatic fractures of the diaphyseal (subtrochanteric or shaft) part of the femur have been observed in patients taking bisphosphonates. We calculated the incidence of these fractures within a defined population and examined the incidence rates according to duration of bisphosphonate use. We identified all femur fractures from January 1, 2007 until December 31, 2011 in 1,835,116 patients older than 45 years who were enrolled in the Healthy Bones Program at Kaiser Southern California, an integrated health care provider. Potential atypical fractures were identified by diagnostic or procedure codes and adjudicated by examination of radiographs. Bisphosphonate exposure was derived from internal pharmacy records. The results showed that 142 patients had atypical fractures; of these, 128 had bisphosphonate exposure. There was no significant correlation between duration of use (5.5 ± 3.4 years) and age (69.3 ± 8.6 years) or bone density (T-score -2.1 ± 1.0). There were 188,814 patients who had used bisphosphonates. The age-adjusted incidence rates for an atypical fracture were 1.78/100,000/year (95% confidence interval [CI], 1.5-2.0) with exposure from 0.1 to 1.9 years, and increased to 113.1/100,000/year (95% CI, 69.3-156.8) with exposure from 8 to 9.9 years. We conclude that the incidence of atypical fractures of the femur increases with longer duration of bisphosphonate use. The rate is much lower than the expected rate of devastating hip fractures in elderly osteoporotic patients. Patients at risk for osteoporotic fractures should not be discouraged from initiating bisphosphonates, because clinical trials have documented that these medicines can substantially reduce the incidence of typical hip fractures. The increased risk of atypical fractures should be taken into consideration when continuing bisphosphonates beyond 5 years.
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                Author and article information

                Journal
                Journal of Bone and Mineral Research
                J Bone Miner Res
                Wiley
                08840431
                August 2018
                August 2018
                August 09 2018
                : 33
                : 8
                : 1394-1396
                Affiliations
                [1 ]Bone Biology Division, Garvan Institute of Medical Research, Darlinghurst, Sydney, NSW, Australia; School of Medicine Sydney, University of Notre Dame Australia, Darlinghurst, Sydney, NSW, Australia; St Vincent's Clinical School, Faculty of Medicine, UNSW Sydney, Sydney, NSW, Australia; Endocrinology, St Vincent's Hospital, Sydney, NSW, Australia; Care and Public Health Research Institute; Maastricht University Medical Center; Maastricht The Netherlands
                [2 ]Department of Internal Medicine, VieCuri Medical Centre, Venlo, The Netherlands; Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands; Faculty of Mediciney; University Hasselt; Maastricht Belgium
                [3 ]Department of Rheumatology, Maastricht University, The Netherlands; Faculty of Medicine; University Hasselt; Belgium
                Article
                10.1002/jbmr.3539
                eb2cc212-79c4-4611-8f72-57cc1850b7eb
                © 2018

                http://doi.wiley.com/10.1002/tdm_license_1.1

                http://creativecommons.org/licenses/by/4.0/

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