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Clinical Trials/NCT06502301
NCT06502301
Completed
Not Applicable

Evaluation of Balance With Computerized Posturography Device and Clinical Tests in Patients With Postmenopausal Osteoporosis

Istanbul University - Cerrahpasa (IUC)1 site in 1 country95 target enrollmentNovember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postmenopausal Osteoporosis
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
95
Locations
1
Primary Endpoint
Computed static posturography
Status
Completed
Last Updated
last year

Overview

Brief Summary

Osteoporosis is defined as low bone mineral density caused by altered bone microstructure, ultimately predisposing patients to fragility fractures. Osteoporotic fractures lead to a significant decrease in quality of life, increasing morbidity, mortality, and disability. Vertebral fracture may cause sagittal imbalance which leading to postural instability and becomes a possible risk factor for falls. The cause of balance problems in osteoporotic patients is multifactorial including increased thoracic kyphosis and postural sway, however the exact relationship between vertebral fractures and balance remains unclear. The aim of the study is; to evaluate the effect of the presence of a vertebral fracture on balance and physical performance and its contribution to fall and fracture risk in patients with postmenopausal osteoporosis.

Detailed Description

Osteoporosis is a metabolic bone disease characterized by low bone mass, deterioration of bone tissue, and disruption of bone microarchitecture . It is known that the incidence of vertebral fractures in women with osteoporosis increases especially after the age of 50. In the United States, one in four women older than 50 years suffers at least one osteoporosis-related vertebral compression fractures. Approximately one-third of vertebral fractures become symptomatic . Vertebral fracture may cause increased dorsal kyphosis and, the center of gravity of the body moves forward. Impaired postural stability is associated with fall risk and functional disability . Many authors argue that the osteoporotic vertebral fractures are associated with an increase in the thoracic curve. There are studies revealing that hyperkyphosis may be a clinically useful marker for history of vertebral fracture and also a risk factor for a new vertebral fracture. Postmenopausal women with vertebral fracture have a 4-fold increased risk of new fractures compared to whom without spinal fracture. Recent vertebral fractures have a strong impact on daily living activities and are significant predictors of poor performance in functional status of the patient. However this triangle among vertebral fractures, kyphosis and balance has not been well documented in the literature. The vertebral fracture cascade phenomena raises the possibility that multiple factors, such as spinal characteristics, vertebral alignment, spinal curvature, and spinal loads, as well as low bone mineral density, may have an impact on falls and fractures. Vertebral fracture may cause sagittal imbalance which leading to postural instability and becomes a possible risk factor for falls. Especially in osteoporotic elderly; falls are associated with high morbidity and mortality. However the effect of a vertebral fracture, as a preventable risk factor on balance impairment has not been studied sufficiently. In this study, we aimed to assess the effect of the presence of a vertebral fracture on balance and physical performance and its additional contribution to fall and fracture risk in patients with postmenopausal osteoporosis.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
February 28, 2021
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Dilara Okutan Kuzu

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Patients aged 50 years or older
  • Diagnosis of postmenopausal osteoporosis according to WHO (World Health Organization) criteria and/or osteoporotic vertebral fractures

Exclusion Criteria

  • A history of neurological and/or vestibular system disease
  • Using a medication that may affect balance and proprioception
  • The presence of a psychotic disorder
  • A history of lower extremity surgery in the last 6 months

Outcomes

Primary Outcomes

Computed static posturography

Time Frame: Baseline

Computerized systems play a crucial role in the quantitative and dynamic evaluation of balance function. The Tetrax device, a computerized static posturography system developed by Sunlight Medical Ltd, Israel, was utilized in our study. This device is valuable for both diagnosis and treatment purposes, offering quantitative assessment of balance. Participants underwent evaluation using the Tetrax device, which involved 32-second measurements in eight different positions. The device calculates several parameters including the Stability Index (SI), Fall Index (FI), and Fourier frequencies, providing objective measures of balance function.

Secondary Outcomes

  • Tandem stance test(10 second)
  • Fracture Risk Assessment tool (FRAX)(Baseline)
  • Berg balance scale (BBS)(Baseline)
  • Timed and go test (TUG)(Baseline)
  • Tandem gait test(Baseline)
  • Dual-energy x-ray absorptiometry measurements(Baseline)

Study Sites (1)

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