Post-Stroke Osteopathy

Fall Clinical Trial

Official title:

Post-Stroke Osteopathy: Characterization of Fractures and Changes in the Bone Microstructure After Ischemic Stroke or TIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845269
• Other study ID #: VASC-E3-2020-06
• Status: Completed
• Start date: March 31, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: VASCage GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The sudden biomechanical inactivation, direct neuro-humoral effects and sustained systemic stress reaction, which commonly occur after stroke or TIA, all may be of relevance in triggering alterations in bone metabolism and remodelling of bone microstructure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Inclusion in the STROKE-CARD Registry Study

• 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:

• Persistent motor deficit before the onset event

• 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

Related Conditions & MeSH terms

• Fall
• Fracture
• Stroke
• Stroke (CVA) or TIA

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck, Department of Neurology	Innsbruck

Sponsors (2)

Lead Sponsor	Collaborator
VASCage GmbH	Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

References & Publications (8)

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. — View Citation

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. Erratum In: Lancet. 2019 Jun 22;393(10190):e44. Lancet. 2018 Nov 17;392(10160):2170. — View Citation

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. — View Citation

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. — View Citation

Ramnemark A, Nyberg L, Borssen B, Olsson T, Gustafson Y. Fractures after stroke. Osteoporos Int. 1998;8(1):92-5. doi: 10.1007/s001980050053. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in imaging bone structure between the baseline and follow-up in all extremities as measured by quantitative CT imaging		12 months
Other	Number and circumstances (housing situation, concomitant medication, level of immobility,...) of falls between baseline and one-year follow-up	Due to the observational nature of the study, these outcome parameters will be published with descriptive statistics	12 months
Other	Change in blood bone biomarkers (as mentioned before) between baseline and follow-up	CTX1 und CTX 2, Osteocalcin, TRAP5b, Bone Alkaline Phosphatase, Sclerostin, Periostin, RANKL-OPG-Ratio	12 months
Other	Circumstances (housing situation, concomitant medication, level of immobility,...) of fractures during the twelve-month follow up		12 months
Primary	Number of patients with and without fractures		12 months

External Links

•   Datasheet of the µCT