The effectiveness of ibandronate in reducing the risk of nonvertebral fractures in women with osteoporosis: systematic review and meta-analysis of observational studies
Carlos AlvesDiogo MendesAna PenedonesTânia Toledo de OliveiraAntónio Augusto DonatoFrancisco Batel Marques
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Abstract Background Ibandronate is effective in reducing the risk of vertebral fractures, but experimental evidence offers conflicting results regarding nonvertebral fractures. Real-world evidence has been published evaluating the anti-nonvertebral fracture effect of ibandronate. Aim This meta-analysis of observational studies assessed the effectiveness of ibandronate in reducing the risk of nonvertebral fractures in women with osteoporosis. Method Pubmed/Embase databases were searched for observational studies. Risks of nonvertebral fractures and hip fractures were the outcomes. Meta-analyses were performed pooling rate ratios (RRs), using random-effects models. Data were reanalysed in sensitivity analyses considering Knapp–Hartung method and Bayesian random-effects. Results Six cohort studies were included. Overall, once-monthly 150 mg oral ibandronate reduced the risk of nonvertebral fractures (RR 0.84; 95% CI 0.76–0.94). Similar results were obtained when the comparison was restricted to once-monthly 150 mg risedronate, but no differences were found when the comparator was other oral bisphosphonates (weekly alendronate/risedronate). Ibandronate didn’t significantly change the risk of hip fractures (RR 1.25; 95% CI 0.89–1.76). The risk of hip fracture was comparable between once monthly, 150 mg oral ibandronate and other oral bisphosphonates. Intravenous ibandronate was not effective in reducing hip fractures comparing to intravenous zoledronate. The low number of studies diminished the robustness of sensitivity analyses. Conclusion Results suggest that once-monthly 150 mg oral ibandronate may be as effective as other oral bisphosphonates in reducing the risk of nonvertebral fractures. However, uncertainty associated to the small number of included studies, which are characterized by heterogeneous demographics and methodologies, precluded definitive conclusions.Keywords:
Hip Fracture
Abstract Background There have been ongoing efforts to understand when and how data from observational studies can be applied to clinical and regulatory decision making. The objective of this review was to assess the comparability of relative treatment effects of pharmaceuticals from observational studies and randomized controlled trials (RCTs). Methods We searched PubMed and Embase for systematic literature reviews published between January 1, 1990, and January 31, 2020, that reported relative treatment effects of pharmaceuticals from both observational studies and RCTs. We extracted pooled relative effect estimates from observational studies and RCTs for each outcome, intervention-comparator, or indication assessed in the reviews. We calculated the ratio of the relative effect estimate from observational studies over that from RCTs, along with the corresponding 95% confidence interval (CI) for each pair of pooled RCT and observational study estimates, and we evaluated the consistency in relative treatment effects. Results Thirty systematic reviews across 7 therapeutic areas were identified from the literature. We analyzed 74 pairs of pooled relative effect estimates from RCTs and observational studies from 29 reviews. There was no statistically significant difference (based on the 95% CI) in relative effect estimates between RCTs and observational studies in 79.7% of pairs. There was an extreme difference (ratio < 0.7 or > 1.43) in 43.2% of pairs, and, in 17.6% of pairs, there was a significant difference and the estimates pointed in opposite directions. Conclusions Overall, our review shows that while there is no significant difference in the relative risk ratios between the majority of RCTs and observational studies compared, there is significant variation in about 20% of comparisons. The source of this variation should be the subject of further inquiry to elucidate how much of the variation is due to differences in patient populations versus biased estimates arising from issues with study design or analytical/statistical methods.
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72 preschoolers and 72 school children observed the original discrimination of nonreversal shift (NRS) followed by 14 NRS trials by themselves. The observational trials were 10 or 30 in each age group. The correct (_??_) or incorrect (×) responses on the 1st (unchanged pair) and the 2nd (changed pair) trials of NRS were mainly measured. In preschoolers, both dependent observational-learning mode (_??_-× responses: DOL) and independent observational-learning mode (_??_-_??_ and ×-×: IOL) were found, but no observational-trial effects on the modes were found. In school children, DOL occurred significantly more than IOL in both groups, and the observational-trial effect was also found. Subproblem analyses suggested that the _??_-× responses were indeed the “dependent” mode rather than the “independent” one.
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The authors prospectively studied the association between quantity and type of alcohol intake and risk of hip fracture among 17, 868 men and 13, 917 women. Analyses were based on pooled data from three population studies conducted in 1964–1992 in Copenhagen, Denmark. During follow-up, 500 first hip fractures were identified in women and 307 in men. A low to moderate weekly alcohol intake (1–27 drinks for men and 1–13 drinks for women) was not associated with hip fracture. Among men, the relative risk of hip fracture gradually increased for those who drank 28 drinks or more per week (relative risk (RR) = 1.75, 95% confidence interval (Cl) 1.06–2.89 for 28–41 drinks; RR = 5.28, 95% Cl 2.60–10.70 for 70 or more drinks) as compared with abstainers. Women who drank 14–27 drinks per week had an age-adjusted relative risk of hip fracture of 1.44 (95% Cl 1.03–2.03), but the association weakened after adjustment for confounders (RR = 1.32, 95% Cl 0.92–1.87). The risk of hip fracture differed according to the type of alcohol preferred: preferrers of beer had a higher risk of hip fracture (RR = 1.46, 95% Cl 1.11–1.91) than preferrers of other types of alcoholic beverages. The corresponding relative risks for preferrers of wine and spirits were 0.77 (95% Cl 0.58–1.03) and 0.82 (95% Cl 0.58–1.14), respectively. In conclusion, an alcohol intake within the current European drinking limits does not influence the risk of hip fracture, whereas an alcohol intake of more than 27 drinks per week is a major risk factor for men. Am J Epidemiol 1999; 149: 993–1001.
Hip Fracture
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Recent studies have indicated higher risk of fractures among coffee drinkers. To quantitatively assess the association between coffee consumption and the risk of fractures, we conducted this meta-analysis.We searched MEDLINE and EMBASE for prospective studies reporting the risk of fractures with coffee consumption. Quality of included studies was assessed with the Newcastle Ottawa scale. We conducted a meta-analysis and a cumulative meta-analysis of relative risk (RR) for an increment of one cup of coffee per day, and explored the potential dose-response relationship. Sensitivity analysis was performed where statistical heterogeneity existed.We included 10 prospective studies covering 214,059 participants and 9,597 cases. There was overall 3.5% higher fracture risk for an increment of one cup of coffee per day (RR = 1.035, 95% CI: 1.019-1.052). Pooled RRs were 1.049 (95% CI: 1.022-1.077) for women and 0.910 (95% CI: 0.873-0.949) for men. Among women, RR was 1.055 (95% CI: 0.999-1.114) for younger participants, and 1.047 (95% CI: 1.016-1.080) for older ones. Cumulative meta-analysis indicated that risk estimates reached a stabilization level (RR = 1.035, 95% CI: 1.019-1.052), and it revealed a positive dose-response relationship between coffee consumption and risk of fractures either for men and women combined or women specifically.This meta-analysis suggests an overall harm of coffee intake in increasing the risk of fractures, especially for women. But current data are insufficient to reach a convincing conclusion and further research needs to be conducted.
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The purposes of this study were to develop and implement an observational training program and to assess the effects of a video observational training program on video and live observational proficiency. Physical education majors took a pretest in both a video and a live environment to assess observational proficiency. The task was observing children batting and answering questions regarding the critical features of the movement. The students were then placed into either a treatment ( n = 12) or a control ( n = 11) group. There were no differences between groups on either assessment ( p > .05). The treatment group then participated in a video observational training program. After the training, all subjects took a posttest in each environment to assess observational proficiency. The training was found to be effective in improving video observational proficiency ( p < .05) but not live observational proficiency ( p > .05). These results provide support for the effectiveness of video observational training in developing video observational proficiency but not live observational proficiency.
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Observational methods such as OW AS. RULA. and REBA have been widely used to identify posture-related risks of musculoskeletal disorders in industry, since they are useful and efficient in evaluating postural stresses. However. there are few studies comparing the methods and providing guidelines for selecting and using the methods. They have been developed based on different backgrounds and with different application areas. Each method has its own characteristics. which must be considered in selecting and using them. In this study. 17 male subjects evaluated 42 different working postures that frequently assumed in the automobile assembly line using a psychophysical method. The postures were then evaluated by different observational methods. The results of the observational methods were compared with psychophysically evaluated stresses. The observational methods resulted in different values of stresses for certain postures. For some postures showing high values of perceived discomfort. the observational methods showed different values of stresses. These results showed that the observational methods should be used differently according to application area and they have some weak points to be improved.
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Studies can be observational or experimental. With an observational study, the investigator does not determine the assignment of subjects, and there might not be a control group. If there is a control group, assignment of the independent variable (exposure or intervention) is not under the control of the investigator. Observational studies can be rigorously conducted, but the lack of random assignment of the exposure/intervention introduces confounding and bias. Thus, the quality of evidence resulting from observational studies is lower than that of experimental randomized controlled trials (RCTs). An observational study might be performed if an RCT is unethical, impractical, or outside the control of the investigator. There are many types of prospective and retrospective observational study designs. However, an observational study design should be avoided if an experimental study is possible. Sophisticated statistical approaches can be used, but this does not elevate an observational study to the level of an RCT. Regardless of quality, an observational study cannot establish causality.
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The article describes the basic rules for conducting observational studies, in particular, registers. The principles of the assessment of its quality and impact on the results are discussed. The potential for evaluating therapeutic effect and side effects in randomized controlled trials (RCTs) and observational studies is compared. Effects of one drug identified in RCTs and observational studies are compared.
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