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To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.amjmed.2008.09.030 Byline: Stuart L. Silverman Keywords: Health care databases; Observational studies; Osteoporosis; Randomized controlled trials; Treatment effectiveness Abstract: Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety. Author Affiliation: Clinical Professor of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine UCLA, OMC Clinical Research Center, Beverly Hills, Calif Article Note: (footnote) Funding: The author received editorial support in the preparation of this manuscript funded by The Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals and sanofi-aventis U.S., Inc). The author, however, was fully responsible for all content and editorial decisions and received no financial support or other form of compensation related to the development of the article., Conflict of interest: The author is a consultant and speaker for The Alliance for Better Bone Health and has received research grant support., Authorship: The author had access to the data and maintained complete control of manuscript development.

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.amjmed.2008.12.002 Byline: Ethel S. Siris (a), Peter L. Selby (b), Kenneth G. Saag (c), Fredrik Borgstrom (d)(e), Ron M.C. Herings (f), Stuart L. Silverman (g) Keywords: Adherence; Compliance; Fracture; Osteoporosis; Persistence Abstract: Fragility fractures associated with osteoporosis constitute a significant public health concern. Clinical trials have shown that a variety of agents -- bisphosphonates, raloxifene, calcitonin, hormone replacement therapy, teriparatide, and strontium ranelate -- can reduce the risk of osteoporosis-related fragility fractures. However, low levels of compliance and persistence in the real-life setting mean that efficacy benefits observed in clinical trials with these agents may not translate into equivalent effectiveness in daily practice. The aim of this review is to provide a comprehensive evaluation of compliance and persistence data from retrospective/observational studies, with particular reference to studies that consider the effects on fracture rates. PubMed of the National Center for Biotechnology Information (NCBI) and Web of Science databases were searched for publications detailing observational or retrospective analyses of adherence, compliance, and persistence with osteoporosis therapies. In addition, authors provided relevant studies that were not retrieved using the search criteria. In total, 17 unique publications were identified. Analysis of the publications indicated that low compliance and persistence rates for osteoporosis therapies in the real-life setting result in increased rates of fragility fractures. The results emphasize the importance of good treatment compliance and persistence with osteoporosis therapies in order to achieve a significant therapeutic benefit and thereby reduce the burden that osteoporosis and associated fractures place on individuals and healthcare systems. Author Affiliation: (a) Toni Stabile Osteoporosis Center and the Metabolic Bone Diseases Program, Department of Medicine, Columbia University Medical Center, New York, New York, USA (b) Department of Medicine, Manchester Royal Infirmary, Manchester, England, United Kingdom (c) Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA (d) Medical Management Center, Karolinska Institute, Stockholm, Sweden (e) i3 Innovus, Stockholm, Sweden (f) PHARMO Institute, Utrecht, Netherlands (g) David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California, USA Article Note: (footnote) Statement of author disclosure: Please see the Author Disclosures section at the end of this article.

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.amjmed.2008.12.005 Byline: Stuart L. Silverman (a), Regina Landesberg (b) Keywords: Bisphosphonate treatment; Intravenous bisphosphonate; Osteonecrosis of the jaw; Osteoporosis; Paget disease Abstract: Osteonecrosis of the jaw (ONJ), a condition characterized by necrotic exposed bone in the maxillofacial region, has been reported in patients with cancer receiving bisphosphonate therapy, and rarely in patients with postmenopausal osteoporosis or Paget disease of bone receiving such therapy. In the absence of a uniform definition, the American Academy of Oral and Maxillofacial Surgeons (AAOMS), the American Society for Bone and Mineral Research (ASBMR), and other groups have established similar diagnostic criteria for bisphosphonate-related ONJ, which is more commonly reported in patients with advanced malignancies with skeletal metastases who receive higher doses, and is more rarely reported in patients with osteoporosis and Paget disease who receive lower doses. However, a critical review of the literature reveals that the etiology of ONJ remains unknown, and to date no direct causal link to bisphosphonates has been established. Despite an increased awareness of ONJ and recent improvements in preventive strategies, patients and physicians alike continue to express concern about the potential risks of bisphosphonate treatment in both oncologic and nononcologic settings. Although much remains to be learned about this condition, including its true incidence in various patient populations, its pathophysiology, and optimal clinical management, evidence to date suggests that the positive benefits of bisphosphonates in patients with malignant bone disease, osteoporosis, or Paget disease outweigh the relatively small risk of ONJ. Author Affiliation: (a) Cedars-Sinai Medical Center and David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California, USA (b) Division of Oral and Maxillofacial Surgery, Columbia University, New York, New York, USA Article Note: (footnote) Statement of author disclosure: Please see the Author Disclosures section at the end of this article.