Clinical trial NCT06502301: How Vertebral Fractures Effect Balance In Postmenopausal Women
Official title: Evaluation of Balance With Computerized Posturography Device and Clinical Tests in Patients With Postmenopausal Osteoporosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Osteoporosis
Vertebral Fracture
Fracture of Vertebra
Fall
Keywords: balance
computed static posturography
fall
FRAX
vertebral fracture
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 95
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 95 patients, at the age of 50 and above with postmenopausal osteoporosis and/or osteoporotic vertebral fractures according to WHO criteria were included in this study.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Computed static posturography
timeFrame: Baseline
Secondary outcomes:
measure: Timed and go test (TUG)
timeFrame: Baseline
measure: Berg balance scale (BBS)
timeFrame: Baseline
measure: Tandem stance test
timeFrame: 10 second
measure: Tandem gait test
timeFrame: Baseline
measure: Fracture Risk Assessment tool (FRAX)
timeFrame: Baseline
measure: Dual-energy x-ray absorptiometry measurements
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Sansin Tuzun
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Dilara Okutan Kuzu
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Rana Kaynar Terlemez
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Deniz Palamar Kadioglu
role: STUDY_CHAIR
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