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      Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax ®) for osteoporosis treatment

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      PLoS ONE

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          Abstract

          Introduction

          Although the same efficacy and tolerability are anticipated due to both drugs containing the same active ingredients, comparative studies between brand and generic alendronate are limited. Accordingly, the objective of this study was to compare efficacy and safety between brand alendronate and a recently introduced generic alendronate drug.

          Methods

          A total of 140 postmenopausal women or men aged older than 50 years who met the indications for osteoporosis treatment were randomized to receive either generic (Bonmax ®) or brand alendronate (Fosamax ®) 70 mg/week over a 12-month period during the May 2014 to June 2015 study period. Endpoints included bone mineral density (BMD) changes at the lumbar spine, total hip, and femoral neck; percentage of patients with predefined levels of change in total hip and lumbar spine BMD at 12 months; and, changes in biochemical bone markers at 3, 6, and 12 months. Tolerability was evaluated by patient self-reporting of adverse experiences.

          Results

          At 12 months post-treatment, BMD significantly increased at all sites in both groups. There were no differences in BMD percentage changes or the number of patients with stable or increased BMD after 1 year between groups. No significant differences in the amount of biochemical bone marker reduction or incidence of adverse events were observed between groups.

          Conclusions

          Generic and brand alendronate produced similar gains in BMD and reduction in bone turnover markers. Both medicadoitions were also equally well-tolerated. Based on these findings, generic alendronate (Bonmax ®) is a viable alternative to the original brand of alendronate.

          Trial registration

          ClinicalTrials.gov NCT02371252

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          Most cited references 28

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          Ten years' experience with alendronate for osteoporosis in postmenopausal women.

          Antiresorptive agents are widely used to treat osteoporosis. We report the results of a multinational randomized, double-blind study, in which postmenopausal women with osteoporosis were treated with alendronate for up to 10 years. The initial three-year phase of the study compared three daily doses of alendronate with placebo. Women in the original placebo group received alendronate in years 4 and 5 and then were discharged. Women in the original active-treatment groups continued to receive alendronate during the initial extension (years 4 and 5). In two further extensions (years 6 and 7, and 8 through 10), women who had received 5 mg or 10 mg of alendronate daily continued on the same treatment. Women in the discontinuation group received 20 mg of alendronate daily for two years and 5 mg daily in years 3, 4, and 5, followed by five years of placebo. Randomized group assignments and blinding were maintained throughout the 10 years. We report results for the 247 women who participated in all four phases of the study. Treatment with 10 mg of alendronate daily for 10 years produced mean increases in bone mineral density of 13.7 percent at the lumbar spine (95 percent confidence interval, 12.0 to 15.5 percent), 10.3 percent at the trochanter (95 percent confidence interval, 8.1 to 12.4 percent), 5.4 percent at the femoral neck (95 percent confidence interval, 3.5 to 7.4 percent), and 6.7 percent at the total proximal femur (95 percent confidence interval, 4.4 to 9.1 percent) as compared with base-line values; smaller gains occurred in the group given 5 mg daily. The discontinuation of alendronate resulted in a gradual loss of effect, as measured by bone density and biochemical markers of bone remodeling. Safety data, including fractures and stature, did not suggest that prolonged treatment resulted in any loss of benefit. The therapeutic effects of alendronate were sustained, and the drug was well tolerated over a 10-year period. The discontinuation of alendronate resulted in the gradual loss of its effects. Copyright 2004 Massachusetts Medical Society
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            Making the first fracture the last fracture: ASBMR task force report on secondary fracture prevention.

            Fragility fractures are common, affecting almost one in two older women and one in three older men. Every fragility fracture signals increased risk of future fractures as well as risk of premature mortality. Despite the major health care impact worldwide, currently there are few systems in place to identify and "capture" individuals after a fragility fracture to ensure appropriate assessment and treatment (according to national guidelines) to reduce future fracture risk and adverse health outcomes. The Task Force reviewed the current evidence about different systematic interventional approaches, their logical background, as well as the medical and ethical rationale. This included reviewing the evidence supporting cost-effective interventions and developing a toolkit for reducing secondary fracture incidence. This report presents this evidence for cost-effective interventions versus the human and health care costs associated with the failure to address further fractures. In particular, it summarizes the evidence for various forms of Fracture Liaison Service as the most effective intervention for secondary fracture prevention. It also summarizes the evidence that certain interventions, particularly those based on patient and/or community-focused educational approaches, are consistently, if unexpectedly, ineffective. As an international group, representing 36 countries throughout Asia-Pacific, South America, Europe, and North America, the Task Force reviewed and summarized the international data on barriers encountered in implementing risk-reduction strategies. It presents the ethical imperatives for providing quality of care in osteoporosis management. As part of an implementation strategy, it describes both the quality improvement methods best suited to transforming care and the research questions that remain outstanding. The overarching outcome of the Task Force's work has been the provision of a rational background and the scientific evidence underpinning secondary fracture prevention and stresses the utility of one form or another of a Fracture Liaison Service in achieving those quality outcomes worldwide. © 2012 American Society for Bone and Mineral Research. Copyright © 2012 American Society for Bone and Mineral Research.
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              Improvement in spine bone density and reduction in risk of vertebral fractures during treatment with antiresorptive drugs.

              To estimate how much the improvement in bone mass accounts for the reduction in risk of vertebral fracture that has been observed in randomized trials of antiresorptive treatments for osteoporosis. After a systematic search, we conducted a meta-analysis of 12 trials to describe the relation between improvement in spine bone mineral density and reduction in risk of vertebral fracture in postmenopausal women. We also used logistic models to estimate the proportion of the reduction in risk of vertebral fracture observed with alendronate in the Fracture Intervention Trial that was due to improvement in bone mineral density. Across the 12 trials, a 1% improvement in spine bone mineral density was associated with a 0.03 decrease (95% confidence interval [CI]: 0.02 to 0.05) in the relative risk (RR) of vertebral fracture. The reductions in risk were greater than predicted from improvement in bone mineral density; for example, the model estimated that treatments predicted to reduce fracture risk by 20% (RR = 0.80), based on improvement in bone mineral density, actually reduce the risk of fracture by about 45% (RR = 0.55). In the Fracture Intervention Trial, improvement in spine bone mineral density explained 16% (95% CI: 11% to 27%) of the reduction in the risk of vertebral fracture with alendronate. Improvement in spine bone mineral density during treatment with antiresorptive drugs accounts for a predictable but small part of the observed reduction in the risk of vertebral fracture.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                5 July 2017
                2017
                : 12
                : 7
                Affiliations
                Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
                Garvan Institute of Medical Research, AUSTRALIA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                • Conceptualization: AU AJ PS.

                • Data curation: AU AJ.

                • Formal analysis: AU AJ.

                • Funding acquisition: AU PS.

                • Investigation: AU AJ.

                • Methodology: AU AJ PS.

                • Project administration: AU PS.

                • Resources: AU PS.

                • Supervision: AU.

                • Validation: AU AJ PS.

                • Visualization: AU AJ PS.

                • Writing – original draft: AU AJ.

                • Writing – review & editing: AU PS.

                Article
                PONE-D-17-00713
                10.1371/journal.pone.0180325
                5498028
                28678853
                © 2017 Unnanuntana et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                Page count
                Figures: 3, Tables: 4, Pages: 14
                Product
                Funding
                Funded by: The Medical Association of Thailand (Prasert Prasarttong-Osoth) Research Fund
                Award Recipient :
                This study was partially supported by the Medical Association of Thailand (Prasert Prasarttong- Osoth) Research Fund. There was no additional external funding received for this study.
                Categories
                Research Article
                Biology and Life Sciences
                Anatomy
                Musculoskeletal System
                Pelvis
                Hip
                Medicine and Health Sciences
                Anatomy
                Musculoskeletal System
                Pelvis
                Hip
                Biology and Life Sciences
                Anatomy
                Bone
                Bone Density
                Medicine and Health Sciences
                Anatomy
                Bone
                Bone Density
                Biology and Life Sciences
                Anatomy
                Biological Tissue
                Connective Tissue
                Bone
                Bone Density
                Medicine and Health Sciences
                Anatomy
                Biological Tissue
                Connective Tissue
                Bone
                Bone Density
                Research and Analysis Methods
                Research Design
                Clinical Research Design
                Adverse Events
                Medicine and Health Sciences
                Rheumatology
                Connective Tissue Diseases
                Osteoporosis
                Medicine and Health Sciences
                Pharmacology
                Adverse Reactions
                Medicine and Health Sciences
                Critical Care and Emergency Medicine
                Trauma Medicine
                Traumatic Injury
                Bone Fracture
                Biology and Life Sciences
                Biochemistry
                Metabolism
                Bone and Mineral Metabolism
                Biology and Life Sciences
                Anatomy
                Musculoskeletal System
                Skeleton
                Femur
                Medicine and Health Sciences
                Anatomy
                Musculoskeletal System
                Skeleton
                Femur
                Custom metadata
                Data contains information that could be used to identify study participants and is available upon request from the corresponding author.

                Uncategorized

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