RESUMO
BACKGROUND: Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with osteopenia is unknown. Most fractures in postmenopausal women occur in those with osteopenia, so therapies that are effective in women with osteopenia are needed. METHODS: We conducted a 6-year, double-blind trial involving 2000 women with osteopenia (defined by a T score of -1.0 to -2.5 at either the total hip or the femoral neck on either side) who were 65 years of age or older. Participants were randomly assigned to receive four infusions of either zoledronate at a dose of 5 mg (zoledronate group) or normal saline (placebo group) at 18-month intervals. A dietary calcium intake of 1 g per day was advised, but calcium supplements were not provided. Participants who were not already taking vitamin D supplements received cholecalciferol before the trial began (a single dose of 2.5 mg) and during the trial (1.25 mg per month). The primary end point was the time to first occurrence of a nonvertebral or vertebral fragility fracture. RESULTS: At baseline, the mean (±SD) age was 71±5 years, the T score at the femoral neck was -1.6±0.5, and the median 10-year risk of hip fracture was 2.3%. A fragility fracture occurred in 190 women in the placebo group and in 122 women in the zoledronate group (hazard ratio with zoledronate, 0.63; 95% confidence interval, 0.50 to 0.79; P<0.001). The number of women that would need to be treated to prevent the occurrence of a fracture in 1 woman was 15. As compared with the placebo group, women who received zoledronate had a lower risk of nonvertebral fragility fractures (hazard ratio, 0.66; P=0.001), symptomatic fractures (hazard ratio, 0.73; P=0.003), vertebral fractures (odds ratio, 0.45; P=0.002), and height loss (P<0.001). CONCLUSIONS: The risk of nonvertebral or vertebral fragility fractures was significantly lower in women with osteopenia who received zoledronate than in women who received placebo. (Funded by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12609000593235 .).
Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Doenças Ósseas Metabólicas/tratamento farmacológico , Fraturas Ósseas/prevenção & controle , Ácido Zoledrônico/uso terapêutico , Reação de Fase Aguda/induzido quimicamente , Idoso , Densidade Óssea/efeitos dos fármacos , Conservadores da Densidade Óssea/efeitos adversos , Remodelação Óssea/efeitos dos fármacos , Cálcio/uso terapêutico , Suplementos Nutricionais , Método Duplo-Cego , Feminino , Humanos , Infusões Intravenosas , Análise de Intenção de Tratamento , Irite/induzido quimicamente , Modelos de Riscos Proporcionais , Ácido Zoledrônico/efeitos adversosRESUMO
We present the results from our 12th annual horizon scan of issues likely to impact biological conservation in the future. From a list of 97 topics, our global panel of 25 scientists and practitioners identified the top 15 issues that we believe society may urgently need to address. These issues are either novel in the biological conservation sector or represent a substantial positive or negative step-change in impact at global or regional level. Six issues, such as coral reef deoxygenation and changes in polar coastal productivity, affect marine or coastal ecosystems and seven relate to human and ecosystem-level responses to climate change. Identification of potential forthcoming issues for biological conservation may enable increased preparedness by researchers, practitioners, and decision-makers.
Assuntos
Conservação dos Recursos Naturais , Ecossistema , Biodiversidade , Mudança Climática , Recifes de Corais , Previsões , HumanosRESUMO
BACKGROUND: The inaccurate recording of medicines on admission to hospital is an important cause of medication error. Medication reconciliation has been used to identify and correct these errors. OBJECTIVE: To determine if a multimodal intervention involving medication reconciliation with real-time feedback and education would reduce the number of errors made by medical staff when recording medicines at the time of admission to hospital. DESIGN: Observational study. PARTICIPANTS: Patients admitted to the general medical wards of a teaching hospital were studied prospectively. Patients > or =75 years of age and on > or =5 medications were identified as the 'target group.' INTERVENTION: After admission, a second medication history was taken, and discrepancies were identified and communicated to the medical teams. An educational intervention to encourage prescribers to obtain accurate medication histories was conducted at the same time. MEASUREMENTS: The discrepancy rate was measured before and after the intervention. MAIN RESULTS: There were 470 admissions in the 'target group.' Three hundred and thirty-eight of the admissions (71.9%) had one or more unintentional discrepancies. Although many discrepancies had little potential to cause harm, 33% were rated as clinically significant. During the study the discrepancy rate (prior to reconciliation) fell from 2.6 (SD 2.6) to 1.0 (SD 1.1) per admission (p < 0.0001). This decline in discrepancy rate remained significant (p = 0.001) even when only clinically important discrepancies were included. The proportion of admissions with one or more clinically important discrepancies also decreased during the study from 46% to 24% (p = 0.023). CONCLUSIONS: Errors in the recording of medicines at the time of hospital admission are common. Combining the feedback provided by medication reconciliation with prescriber education reduced the error rate. This approach may be useful when the resources are not available to perform medication reconciliation for all patients admitted to hospital.
Assuntos
Educação Médica , Anamnese , Prontuários Médicos , Erros de Medicação/prevenção & controle , Preparações Farmacêuticas , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Admissão do Paciente , Estudos ProspectivosRESUMO
We recently showed that zoledronate prevented fractures in older women with osteopenia (hip T-scores between -1.0 and -2.5). In addition to fewer fractures, this study also suggested that women randomized to zoledronate had fewer vascular events, a lower incidence of cancer, and a trend to lower mortality. The present analysis provides a more detailed presentation of the adverse event data from that study, a 6-year, double-blind trial of 2000 women aged >65 years recruited using electoral rolls. They were randomly assigned to receive four infusions of either zoledronate 5 mg or normal saline at 18-month intervals. Supplements of vitamin D, but not calcium, were provided. There were 1017 serious adverse events in 443 participants in the placebo group, and 820 events in 400 participants in those randomized to zoledronate (relative risk = 0.90; 95% CI, 0.81 to 1.00). These events included fractures resulting in hospital admission. Myocardial infarction occurred in 39 women (43 events) in the placebo group and in 24 women (25 events) in the zoledronate group (hazard ratio 0.60 [95% CI, 0.36 to 1.00]; rate ratio 0.58 [95% CI, 0.35 to 0.94]). For a prespecified composite cardiovascular endpoint (sudden death, myocardial infarction, coronary artery revascularization, or stroke) 69 women had 98 events in the placebo group, and 53 women had 71 events in the zoledronate group (hazard ratio 0.76 [95% CI, 0.53 to 1.08]; rate ratio 0.72 [95% CI, 0.53 to 0.98]). Total cancers were significantly reduced with zoledronate (hazard ratio 0.67 [95% CI, 0.51 to 0.89]; rate ratio 0.68 [95% CI, 0.52 to 0.89]), and this was significant for both breast cancers and for non-breast cancers. Eleven women had recurrent or second breast cancers during the study, all in the placebo group. The hazard ratio for death was 0.65 (95% CI, 0.40 to 1.06; p = 0.08), and 0.51 (95% CI, 0.30 to 0.87) in those without incident fragility fracture. These apparent beneficial effects justify further appropriately powered trials of zoledronate with these nonskeletal conditions as primary endpoints. © 2019 American Society for Bone and Mineral Research.