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Stroke (CVA) or TIANCT04845269

Post-Stroke Osteopathy

An observational study of Stroke (CVA) or TIA and Fracture, run by VASCage GmbH at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Stroke (CVA) or TIA, Fracture, Fall
How many people
127 participants
Where
1 siteAustria
Study dates
31 Mar 2021to 31 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Innsbruck, Department of Neurology

    Innsbruck, 6020

Other trials in Austria

About this study

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

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.

Keywords
high-resolution peripheral quantitative Computer Tomography, Bone microstructure
Medical subject headings
Stroke, Fractures, Bone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with and without fractures

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start31 Mar 2021
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04845269
Sponsor's protocol ID
VASC-E3-2020-06
Status last verified
Jun 2023
First submitted
7 Apr 2021
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 30496103

  • 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.

    PubMed 27101998

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

    PubMed 9692083

  • 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.

    PubMed 10884456

  • 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.

    PubMed 10187874

  • 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.

    PubMed 19571530

  • 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.

    PubMed 19121416

  • 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.

    PubMed 10450417

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke (CVA) or TIA and Fracture, run by VASCage GmbH at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with and without fractures (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04845269, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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