Viewing Study NCT06502301



Ignite Creation Date: 2024-10-26 @ 3:34 PM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06502301
Status: COMPLETED
Last Update Posted: None
First Post: 2024-07-09

Brief Title: How Vertebral Fractures Effect Balance In Postmenopausal Women
Sponsor: None
Organization: None

Study Overview

Official Title: Evaluation of Balance With Computerized Posturography Device and Clinical Tests in Patients With Postmenopausal Osteoporosis
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None