NCT04845269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

2.2 years

First QC Date

April 7, 2021

Last Update Submit

June 21, 2023

Conditions

Stroke (CVA) or TIAFractureFall

Keywords

high-resolution peripheral quantitative Computer TomographyBone microstructure

Outcome Measures

Primary Outcomes (1)

  • Number of patients with and without fractures

    12 months

Other Outcomes (4)

  • Changes in imaging bone structure between the baseline and follow-up in all extremities as measured by quantitative CT imaging

    12 months

  • Number and circumstances (housing situation, concomitant medication, level of immobility,...) of falls between baseline and one-year follow-up

    12 months

  • Change in blood bone biomarkers (as mentioned before) between baseline and follow-up

    12 months

  • +1 more other outcomes

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Innsbruck, Department of Neurology

Innsbruck, 6020, Austria

Location

Related Publications (8)

  • 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.

    PMID: 30496103BACKGROUND

  • 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.

    PMID: 27101998BACKGROUND

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

    PMID: 9692083BACKGROUND

  • 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.

    PMID: 10884456BACKGROUND

  • 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.

    PMID: 10187874BACKGROUND

  • 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.

    PMID: 19571530BACKGROUND

  • 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.

    PMID: 19121416BACKGROUND

  • 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.

    PMID: 10450417BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

StrokeFractures, Bone

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesWounds and Injuries

Study Officials

  • Michael Knoflach, Assoz.Prof. Priv.-Doz. Dr.

    Medical University of Innsbruck, Department of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 14, 2021

Study Start

March 31, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

AU(1)