FRAX™ and the assessment of fracture probability in men and women from the UK
TL;DR: The models provide a framework which enhances the assessment of fracture risk in both men and women by the integration of clinical risk factors alone and/or in combination with BMD.
Abstract: Summary
A fracture risk assessment tool (FRAX™) is developed based on the use of clinical risk factors with or without bone mineral density tests applied to the UK.
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TL;DR: The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer and immune responses to the immunizing antigen were observed in patients who received sipuleUcel- T.
Abstract: Background Sipuleucel-T, an autologous active cellular immunotherapy, has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer. Methods In this double-blind, placebo-controlled, multicenter phase 3 trial, we randomly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T (341 patients) or placebo (171 patients) administered intravenously every 2 weeks, for a total of three infusions. The primary end point was overall survival, analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen (PSA) and lactate dehydrogenase. Results In the sipuleucel-T group, there was a relative reduction of 22% in the risk of death as compared with the placebo group (hazard ratio, 0.78; 95% confidence interval [CI], 0.61 to 0.98; P = 0.03). This reduction represented a 4.1-month improvement in median survival (25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group). The 36-month survival probability was 31.7% in the sipuleucel-T group versus 23.0% in the placebo group. The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test (hazard ratio, 0.77; 95% CI, 0.61 to 0.97; P = 0.02) and after adjustment for use of docetaxel after the study therapy (hazard ratio, 0.78; 95% CI, 0.62 to 0.98; P = 0.03). The time to objective disease progression was similar in the two study groups. Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills, fever, and headache. Conclusions The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer. No effect on the time to disease progression was observed. (Funded by Dendreon; ClinicalTrials.gov number, NCT00065442.)
4,840 citations
TL;DR: The Clinician’s Guide to Prevention and Treatment of Osteoporosis was developed by an expert committee of the National Osteiporosis Foundation in collaboration with a multispecialty council of medical experts in the field of bone health convened by NOF.
Abstract: The Clinician’s Guide to Prevention and Treatment of Osteoporosis was developed by an expert committee of the National Osteoporosis Foundation (NOF) in collaboration with a multispecialty council of medical experts in the field of bone health convened by NOF. Readers are urged to consult current prescribing information on any drug, device, or procedure discussed in this publication.
2,926 citations
TL;DR: In this paper, the European Foundation for Osteoporosis and Bone disease (subsequently the International osteopo- rosis Foundation) published guidelines for the diagnosis and management of osteoporrosis in a European setting.
Abstract: Summary Guidance is provided in a European setting on the assessment and treatment of postmenopausal women with or at risk from osteoporosis. Introduction The European Foundation for Osteoporosis and Bone disease (subsequently the International Osteopo- rosis Foundation) published guidelines for the diagnosis and management of osteoporosis in 1997. This manuscript updates these in a European setting. Methods The following areas are reviewed: the role of bone mineral density measurement for the diagnosis of osteoporo- sis and assessment of fracture risk; general and pharmaco- logical management of osteoporosis; monitoring of treatment; assessment of fracture risk; case finding strategies; investigation of patients; health economics of treatment. Results and conclusions A platform is provided on which specific guidelines can be developed for national use.
2,292 citations
Cites background or methods from "FRAX™ and the assessment of fractur..."
...uk/FRAX) that calculates the 10-year probability of a major fracture (hip, clinical spine, humerus or wrist fracture) and the 10-year probability of hip fracture [8, 75, 76]....
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...These include the Garvan fracture risk calculator [69], QFractureTM [70] and FRAX® [8, 75]....
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Newcastle upon Tyne Hospitals NHS Foundation Trust1, Queen Elizabeth Hospital Birmingham2, University Hospital of Wales3, University of Cambridge4, Royal Hallamshire Hospital5, Royal Liverpool University Hospital6, Cardiff University7, King's College London8, British Thyroid Foundation9, University of Oxford10, Imperial College London11
995 citations
TL;DR: An approach combining the assessment of bone mineral density, clinical risk factors for fracture with use of the FRAX, and bone turnover markers will improve the prediction of fracture risk and enhance the evaluation of patients with osteoporosis.
Abstract: Bone mineral density is considered to be the standard measure for the diagnosis of osteoporosis and the assessment of fracture risk. The majority of fragility fractures occur in patients with bone mineral density in the osteopenic range. The Fracture Risk Assessment Tool (FRAX) can be used as an assessment modality for the prediction of fractures on the basis of clinical risk factors, with or without the use of femoral neck bone mineral density. Treatment of osteoporosis should be considered for patients with low bone mineral density (a T-score of between -1.0 and -2.5) as well as a ten-year risk of hip fracture of > or = 3% or a ten-year risk of a major osteoporosis-related fracture of > or = 20% as assessed with the FRAX. Biochemical bone markers are useful for monitoring the efficacy of antiresorptive or anabolic therapy and may aid in identifying patients who have a high risk of fracture. An approach combining the assessment of bone mineral density, clinical risk factors for fracture with use of the FRAX, and bone turnover markers will improve the prediction of fracture risk and enhance the evaluation of patients with osteoporosis.
653 citations
References
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31 Dec 1980
TL;DR: Statistical methods in cancer research as mentioned in this paper, Statistical Methods in Cancer Research, Statistical methods in Cancer research, Statistical methods for cancer research, کتابخانه مرکزی دانشگاه علوم پزش
Abstract: Statistical methods in cancer research , Statistical methods in cancer research , کتابخانه مرکزی دانشگاه علوم پزشکی تهران
6,164 citations
TL;DR: The SCORE risk estimation system offers direct estimation of total fatal cardiovascular risk in a format suited to the constraints of clinical practice.
Abstract: Aims The SCORE project was initiated to develop a risk scoring system for use in the clinical management of cardiovascular risk in European clinical practice. Methods and results The project assembled a pool of datasets from 12 European cohort studies, mainly carried out in general population settings. There were 205 178 persons (88 080 women and 117 098 men) representing 2.7 million person years of follow-up. There were 7934 cardiovascular deaths, of which 5652 were deaths from coronary heart disease. Ten-year risk of fatal cardiovascular disease was calculated using a Weibull model in which age was used as a measure of exposure time to risk rather than as a risk factor. Separate estimation equations were calculated for coronary heart disease and for non-coronary cardiovascular disease. These were calculated for high-risk and low-risk regions of Europe. Two parallel estimation models were developed, one based on total cholesterol and the other on total
4,842 citations
4,461 citations
TL;DR: Measurements of bone mineral density can predict fracture risk but cannot identify individuals who will have a fracture, and a programme of screening menopausal women for osteoporosis by measuring bone density cannot be recommended.
Abstract: Objective: To determine the ability of measurements of bone density in women to predict later fractures. Design: Meta-analysis of prospective cohort studies published between 1985 and end of 1994 with a baseline measurement of bone density in women and subsequent follow up for fractures. For comparative purposes, we also reviewed case control studies of hip fractures published between 1990 and 1994. Subjects: Eleven separate study populations with about 90000 person years of observation time and over 2000 fractures. Main outcome measures: Relative risk of fracture for a decrease in bone mineral density of one standard deviation below age adjusted mean. Results: All measuring sites had similar predictive abilities (relative risk 1.5 (95% confidence interval 1.4 to 1.6)) for decrease in bone mineral density except for measurement at spine for predicting vertebral fractures (relative risk 2.3 (1.9 to 2.8)) and measurement at hip for hip fractures (2.6 (2.0 to 3.5)). These results are in accordance with results of case-control studies. Predictive ability of decrease in bone mass was roughly similar to (or, for hip or spine measurements, better than) that of a 1 SD increase in blood pressure for stroke and better than a 1 SD increase in serum cholesterol concentration for cardiovascular disease. Conclusions: Measurements of bone mineral density can predict fracture risk but cannot identify individuals who will have a fracture. We do not recommend a programme of screening menopausal women for osteoporosis by measuring bone density. Key messages Measuring bone mineral density has been suggested as a method of identifying individuals at high risk of fracture in a preventive context Our meta-analysis of prospective studies showed that all studies measuring bone density at any site had similar predictive ability for a decrease of 1 SD in bone density except for measurements at hip and spine, which have better predictive ability for fractures in hip and spine respectively Predictive ability of decrease in bone mass was roughly similar to (or, for hip or spine measurements, better than) that of a 1 SD increase in blood pressure for stroke and better than a 1 SD increase in serum cholesterol concentration for cardiovascular disease Although bone mineral density measurements can predict fracture risk, they cannot identify individuals who will have a fracture, and a screening programme for osteoporosis cannot be recommended
3,466 citations
01 Jan 1994
TL;DR: There is little evidence that osteoporosis can usefully be tackled by a public health policy to influence risk factors such as smoking, exercise and nutrition, so the selective use of screening techniques will improve the cost-benefit ratio of intervention.
3,008 citations