Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
127 participants
OBSERVATIONAL
2021-03-31
2023-05-31
Brief Summary
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The objectives of this observational pilot study are to characterize falls and fractures and their circumstances (sex and age specific incidence, time course, risk conditions, localization) in ischemic stroke patients, study changes in the bone microstructure after ischemic stroke supported by high-resolution peripheral quantitative Computer Tomography, unravel a molecular mechanisms underlying the increased fracture risk (focus on Wnt-signaling and ß-adrenergic projection), establish risk factors to estimate the risk of falls based on information from gait analysis as well as construct deep learning algorithms to identify bone microstructure parameters for predicting fractures.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Modified Rankin Scale (mRS) \< 5
* Provision of signed and dated informed consent form
* Willingness to comply with all study procedures and ability to participate in the study over the complete study duration
Exclusion Criteria
* Not able to walk without walking aid or not able to put the full bodyweight on either leg before the onset event
* Medical history of stroke
* Premedication with Corticosteroids for more than 6 Weeks or Pioglitazone or Bisphosphonate within the last 12 months
* Limb amputation
* BMI \< 18,5 kg/m2 or \> 35 kg/m2
* Present or previous fracture in the distal Radius or Tibia interfering with HR-pQCT
* Movement disorder interfering with HR-pQCT imaging
* Women of childbearing potential
60 Years
85 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
VASCage GmbH
OTHER
Responsible Party
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Principal Investigators
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Michael Knoflach, Assoz.Prof. Priv.-Doz. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Innsbruck, Department of Neurology
Locations
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Medical University of Innsbruck, Department of Neurology
Innsbruck, , Austria
Countries
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References
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GBD 2017 Causes of Death Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1736-1788. doi: 10.1016/S0140-6736(18)32203-7. Epub 2018 Nov 8.
Yuan ZC, Mo H, Guan J, He JL, Wu ZJ. Risk of hip fracture following stroke, a meta-analysis of 13 cohort studies. Osteoporos Int. 2016 Sep;27(9):2673-2679. doi: 10.1007/s00198-016-3603-x. Epub 2016 Apr 22.
Ramnemark A, Nyberg L, Borssen B, Olsson T, Gustafson Y. Fractures after stroke. Osteoporos Int. 1998;8(1):92-5. doi: 10.1007/s001980050053.
Ramnemark A, Nilsson M, Borssen B, Gustafson Y. Stroke, a major and increasing risk factor for femoral neck fracture. Stroke. 2000 Jul;31(7):1572-7. doi: 10.1161/01.str.31.7.1572.
Ramnemark A, Nyberg L, Lorentzon R, Olsson T, Gustafson Y. Hemiosteoporosis after severe stroke, independent of changes in body composition and weight. Stroke. 1999 Apr;30(4):755-60. doi: 10.1161/01.str.30.4.755.
Carda S, Cisari C, Invernizzi M, Bevilacqua M. Osteoporosis after stroke: a review of the causes and potential treatments. Cerebrovasc Dis. 2009;28(2):191-200. doi: 10.1159/000226578. Epub 2009 Jun 30.
Poole KE, Vedi S, Debiram I, Rose C, Power J, Loveridge N, Warburton EA, Reeve J, Compston J. Bone structure and remodelling in stroke patients: early effects of zoledronate. Bone. 2009 Apr;44(4):629-33. doi: 10.1016/j.bone.2008.11.017. Epub 2008 Dec 11.
Ramnemark A, Nyberg L, Lorentzon R, Englund U, Gustafson Y. Progressive hemiosteoporosis on the paretic side and increased bone mineral density in the nonparetic arm the first year after severe stroke. Osteoporos Int. 1999;9(3):269-75. doi: 10.1007/s001980050147.
Related Links
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Datasheet of the µCT
Other Identifiers
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VASC-E3-2020-06
Identifier Type: -
Identifier Source: org_study_id
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