Post-Stroke Osteopathy

• ClinicalTrials.gov Identifier: NCT04845269
• Recruitment Status: Active, not recruiting
• First Posted: April 14, 2021
• Last Update Posted: June 24, 2022
• Sponsor: VASCage GmbH
• Collaborator: Medical University Innsbruck
• Information provided by (Responsible Party): VASCage GmbH

Tracking Information

• First Submitted Date: April 7, 2021
• First Posted Date: April 14, 2021
• Last Update Posted Date: June 24, 2022
• Actual Study Start Date: March 31, 2021
• Estimated Primary Completion Date: May 31, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 13, 2021): Number of patients with and without fractures [ Time Frame: 12 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: February 15, 2022)

• Changes in imaging bone structure between the baseline and follow-up in all extremities as measured by quantitative CT imaging [ Time Frame: 12 months ]
• Number and circumstances (housing situation, concomitant medication, level of immobility,...) of falls between baseline and one-year follow-up [ Time Frame: 12 months ]
  Due to the observational nature of the study, these outcome parameters will be published with descriptive statistics
• Change in blood bone biomarkers (as mentioned before) between baseline and follow-up [ Time Frame: 12 months ]
  CTX1 und CTX 2, Osteocalcin, TRAP5b, Bone Alkaline Phosphatase, Sclerostin, Periostin, RANKL-OPG-Ratio
• Circumstances (housing situation, concomitant medication, level of immobility,...) of fractures during the twelve-month follow up [ Time Frame: 12 months ]

Original Other Pre-specified Outcome Measures (submitted: April 13, 2021)

• Changes in imaging bone structure between the baseline and follow-up in all extremities as measured by quantitative CT imaging [ Time Frame: 12 months ]
• Number and circumstances (housing situation, concomitant medication, level of immobility,...) of falls between baseline and one-year follow-up [ Time Frame: 12 months ]
• Change in blood bone biomarkers (as mentioned before) between baseline and follow-up [ Time Frame: 12 months ]
• Circumstances (housing situation, concomitant medication, level of immobility,...) of fractures during the twelve-month follow up [ Time Frame: 12 months ]

Descriptive Information

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

Brief 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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

CTX1 und CTX 2, Osteocalcin, TRAP5b, Bone Alkaline Phosphatase, Sclerostin, Periostin, RANKL-OPG-Ratio

• Sampling Method: Non-Probability Sample
• Study Population: As a sub-study of the STROKE-CARD Registry Study the source population will be all patients treated at the Department of Neurology Innsbruck (Austria) for stroke and included in the STROKE-CARD Registry Study. The target study population for the Post-Stroke Osteopathy Study will be all patients included in the STROKE-CARD Registry Study (clinicaltrials.gov ID NCT04582825).

Condition

• Stroke (CVA) or TIA
• Fracture
• Fall

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• 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.
• 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. Review.
• Ramnemark A, Nyberg L, Borssén B, Olsson T, Gustafson Y. Fractures after stroke. Osteoporos Int. 1998;8(1):92-5.
• Ramnemark A, Nilsson M, Borssén B, Gustafson Y. Stroke, a major and increasing risk factor for femoral neck fracture. Stroke. 2000 Jul;31(7):1572-7.
• 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.
• 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. Review.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 20, 2022): 127
• Original Estimated Enrollment (submitted: April 13, 2021): 200
• Estimated Study Completion Date: May 31, 2023
• Estimated Primary Completion Date: May 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria

Administrative Information

• NCT Number: NCT04845269
• Other Study ID Numbers: VASC-E3-2020-06
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: VASCage GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: VASCage GmbH
• Original Study Sponsor: Same as current
• Collaborators: Medical University Innsbruck

Investigators

• Principal Investigator: Michael Knoflach, Assoz.Prof. Priv.-Doz. Dr.; Medical University of Innsbruck, Department of Neurology

• PRS Account: VASCage GmbH
• Verification Date: June 2022