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
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...
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BMJ Publishing Group
2020-09-01
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| author | Noushin Fahimfar Bagher Larijani Afshin Ostovar Iraj Nabipour Patricia Khashayar Hans Peter Dimai Nahid Moradi Safoora Gharibzadeh |
| author_facet | Noushin Fahimfar Bagher Larijani Afshin Ostovar Iraj Nabipour Patricia Khashayar Hans Peter Dimai Nahid Moradi Safoora Gharibzadeh |
| author_sort | Noushin Fahimfar |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-01e82c1347f3477faa997030993f9b05 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-01e82c1347f3477faa997030993f9b052025-01-08T15:40:12ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-035363Protocol for a multicentre, prospective cohort study of clinical, proteomic and genomic patterns associated with osteoporosis to develop a multidimensional fracture assessment tool: the PoCOsteo StudyNoushin Fahimfar0Bagher Larijani1Afshin Ostovar2Iraj Nabipour3Patricia Khashayar4Hans Peter Dimai5Nahid Moradi6Safoora Gharibzadeh7Osteoporosis Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, IranOsteoporosis Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, IranThe Persian Gulf Marine Biotechnology Research Center, The Persian Gulf Biomedical Sciences Research Institute, Bushehr University of Medical Sciences, Bushehr, Iran (the Islamic Republic of)Center for Microsystems Technology, Imec & Ghent University, Zwijnaarde - Gent, BelgiumDepartment of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Steiermark, Austria1CORe, Neurology, Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, AustraliaDepartment of Epidemiology and Biostatistics, Pasteur Institute of Iran, Tehran, Iran (the Islamic Republic of)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.https://bmjopen.bmj.com/content/10/9/e035363.full |
| spellingShingle | Noushin Fahimfar Bagher Larijani Afshin Ostovar Iraj Nabipour Patricia Khashayar Hans Peter Dimai Nahid Moradi Safoora Gharibzadeh 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/9/e035363.full |
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