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Protocol for a multicentre, prospective cohort study of clinical, proteomic and genomic patterns associated with osteoporosis to develop a multidimensional fracture assessment tool: the PoCOsteo Study.

ABSTRACT: INTRODUCTION:The HORIZON 2020 project PoCOsteo aims (1) to develop a multidimensional fracture risk assessment tool which would take into account all factors known to be related to an individual's fracture risk. The fracture risk model is intended to be developed in two different populations, namely a European and a Middle Eastern one; (2) to develop a medical device, which would measure and/or quantify proteomic as well as genomic factors as present in whole blood samples collected through finger prick; (3) to test the clinical applicability and the validity of prototypes of the to be developed point of care device at both clinical centres. METHODS AND ANALYSIS:This article presents the protocol of this prospective cohort that will be carried out independently at two different centres (Division of Endocrinology and Diabetology at the Medical University of Graz (MUG) as a clinic-based cohort, and Endocrinology and Metabolism Research Institute (EMRI) at the Tehran University of Medical Sciences (TUMS) as a population-based cohort). The final aim is to develop a fracture risk assessment model, which would include clinical risk factors, biochemical markers of bone turnover, as well as specific genomic factors. The derivation cohorts will consist of individuals aged 50 years and above. The period of observation for each patient will be 12 months; an extension phase, which would last for another 2 years, is also planned. ETHICS AND DISSEMINATION:These studies are conducted in accordance with the World Medical Association Declaration of Helsinki. The Iranian part was approved by the Research Ethics Committee of EMRI, TUMS. The Austrian part was approved by the Ethics Committee of the Medical University of Graz. Based on the gathered information, a multidimensional fracture assessment tool will be designed which will later be added to the PoCOsteo device.

SUBMITTER: Khashayar P

PROVIDER: S-EPMC7528352 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Protocol for a multicentre, prospective cohort study of clinical, proteomic and genomic patterns associated with osteoporosis to develop a multidimensional fracture assessment tool: the PoCOsteo Study.

Khashayar Patricia P Dimai Hans Peter HP Moradi Nahid N Fahimfar Noushin N Gharibzadeh Safoora S Ostovar Afshin A Nabipour Iraj I Larijani Bagher B

BMJ open 20200930 9

<h4>Introduction</h4>The HORIZON 2020 project PoCOsteo aims (1) to develop a multidimensional fracture risk assessment tool which would take into account all factors known to be related to an individual's fracture risk. The fracture risk model is intended to be developed in two different populations, namely a European and a Middle Eastern one; (2) to develop a medical device, which would measure and/or quantify proteomic as well as genomic factors as present in whole blood samples collected thro ...[more]

PMID: 32998914

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Project description:ImportanceThe aging of the population is associated with an increasing burden of fractures worldwide. However, the epidemiological features of fractures in mainland China are not well known.ObjectiveTo assess the prevalence of and factors associated with osteoporosis, clinical fractures, and vertebral fractures in an adult population 40 years or older in mainland China.Design, setting. and participantsThis cross-sectional study, the China Osteoporosis Prevalence Study, was conducted from December 2017 to August 2018. A random sample of individuals aged 20 years or older who represented urban and rural areas of China were enrolled, with a 99% participation rate.Main outcomes and measuresWeighted prevalence of osteoporosis, clinical fracture, and vertebral fracture by age, sex, and urban vs rural residence as determined by x-ray absorptiometry, questionnaire, and radiography.ResultsA total of 20 416 participants were included in this study; 20 164 (98.8%; 11 443 women [56.7%]; mean [SD] age, 53 [13] years) had a qualified x-ray absorptiometry image and completed the questionnaire, and 8423 of 8800 (95.7%) had a qualified spine radiograph. The prevalence of osteoporosis among those aged 40 years or older was 5.0% (95% CI, 4.2%-5.8%) among men and 20.6% (95% CI, 19.3%-22.0%) among women. The prevalence of vertebral fracture was 10.5% (95% CI, 9.0%-12.0%) among men and 9.7% (95% CI, 8.2%-11.1%) among women. The prevalence of clinical fracture in the past 5 years was 4.1% (95% CI, 3.3%-4.9%) among men and 4.2% (95% CI, 3.6%-4.7%) among women. Among men and women, 0.3% (95% CI, 0.0%-0.7%) and 1.4% (95% CI, 0.8%-2.0%), respectively, with osteoporosis diagnosed on the basis of bone mineral density or with fracture were receiving antiosteoporosis treatment to prevent fracture.Conclusions and relevanceIn this cross-sectional study of an adult population in mainland China, the prevalence of osteoporosis and vertebral fracture were high and the prevalence of vertebral fracture and clinical fracture was similarly high in men and women. These findings suggest that current guidelines for screening and treatment of fractures among patients in China should focus equally on men and women and should emphasize the prevention of vertebral fractures.

Project description:ObjectiveDespite the fact that China amounts to one-fifth of the world's population, has a higher proportion of the elderly, and has a higher prevalence of osteoporosis and fracture, limited studies have investigated the association between dietary patterns and bone mineral density (BMD) as well as fracture risk among the elderly Chinese population. We aimed to investigate the association between different dietary patterns and BMD as well as the risk of fractures, and this association may vary between elderly women and men.MethodsBuilding upon the China Osteoporosis Prevalence Study, we included 17,489 subjects aged ≥40 years old randomly sampled across 44 counties/districts of 11 provinces or municipalities in China who completed a food frequency questionnaire. BMD was measured by dual x-ray absorptiometry. Vertebral fracture was defined based on lateral spine radiographs using the semi-quantitative technique of Genant.ResultsA diet rich in "carnivorous", "vegetarian", "dairy, fruit, and egg" was significantly associated with higher BMD at total hip (TH), femoral neck (FN), and lumbar spine 1-4 (L1-4). Yet, a diet rich in "beverage and fried food" was associated with a lower BMD at the FN and L1-4. High quartiles of the carnivorous diet were associated with 34%-39% reduced risk of clinical fracture in the past 5 years and vertebral fracture. Stronger associations were observed among women. Sensitivity analysis among postmenopausal women presented even stronger positive associations between carnivorous and vegetarian diets and high BMD, as well as between carnivorous diet and reduced risk of fractures.ConclusionsOur study suggested that a diet rich in meat, vegetables, and dairy, fruit, and eggs might be associated with greater BMD and a lower fracture risk, while beverage and fried foods may be associated with a lower BMD at L1-4, especially among elderly women. These findings are relevant to provide recommendations on dietary nutrition regarding the elderly population at high risk of osteoporosis and fractures, especially postmenopausal women.

Project description:Background: Osteoporotic fractures are defined as low-impact fractures resulting from low-level trauma. However, the exclusion of high-level trauma fractures may result in underestimation of the contribution of osteoporosis to fractures. In this study, we aimed to investigate the fracture patterns of female trauma patients with various risks of osteoporosis based on the Osteoporosis Self-Assessment Tool for Asians (OSTA) score. Methods: According to the data retrieved from the Trauma Registry System of a Level I trauma center between 1 January 2009 and 31 December 2015, a total of 6707 patients aged ?40 years and hospitalized for the treatment of traumatic bone fracture were categorized as high-risk (OSTA < -4, n = 1585), medium-risk (-1 ? OSTA ? -4, n = 1985), and low-risk (OSTA > -1, n = 3137) patients. Two-sided Pearson's, chi-squared, or Fisher's exact tests were used to compare categorical data. Unpaired Student's t-test and Mann-Whitney U-test were used to analyze normally and non-normally distributed continuous data, respectively. Propensity-score matching in a 1:1 ratio was performed with injury mechanisms as adjusted variables to evaluate the effects of OSTA-related grouping on the fracture patterns. Results: High- and medium-risk patients were significantly older, had higher incidences of comorbidity, and were more frequently injured from a fall and bicycle accident than low-risk patients did. Compared to low-risk patients, high- and medium-risk patients had a higher injury severity and mortality. In the propensity-score matched population, the incidence of fractures was only different in the extremity regions between high- and low-risk patients as well as between medium- and low-risk patients. The incidences of femoral fractures were significantly higher in high-risk (odds ratio [OR], 3.4; 95% confidence interval [CI], 2.73-4.24; p < 0.001) and medium-risk patients (OR, 1.4; 95% CI, 1.24-1.54; p < 0.001) than in low-risk patients. In addition, high-risk patients had significantly lower odds of humeral, radial, patellar, and tibial fractures; however, such lower odds were not found in medium- risk than low-risk patients. Conclusions: The fracture patterns of female trauma patients with high- and medium-risk osteoporosis were different from that of low-risk patients exclusively in the extremity region.

Dataset Information

Protocol for a multicentre, prospective cohort study of clinical, proteomic and genomic patterns associated with osteoporosis to develop a multidimensional fracture assessment tool: the PoCOsteo Study.

Publications

Protocol for a multicentre, prospective cohort study of clinical, proteomic and genomic patterns associated with osteoporosis to develop a multidimensional fracture assessment tool: the PoCOsteo Study.

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