How Vertebral Fractures Effect Balance In Postmenopausal Women
- Conditions
- Fracture of VertebraFallVertebral FracturePostmenopausal Osteoporosis
- Interventions
- Other: Cross-sectional study
- Registration Number
- NCT06502301
- Lead Sponsor
- Istanbul University - Cerrahpasa (IUC)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 95
- Patients aged 50 years or older
- Diagnosis of postmenopausal osteoporosis according to WHO (World Health Organization) criteria and/or osteoporotic vertebral fractures
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Postmenopausal women with vertebral fractures Cross-sectional study Thoracolumbar radiograph, computed static posturography, fracture risk assessment tool (FRAX) scores, Dual-energy x-ray absorptiometry (DXA) measurements, serum 25(OH)D values, tandem test, timed up and go test (TUG), Berg balance scale (BBS) were performed. Postmenopausal women without vertebral fractures Cross-sectional study Thoracolumbar radiograph, computed static posturography, fracture risk assessment tool (FRAX) scores, Dual-energy x-ray absorptiometry (DXA) measurements, serum 25(OH)D values, tandem test, timed up and go test (TUG), Berg balance scale (BBS) were performed.
- Primary Outcome Measures
Name Time Method Computed static posturography 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 Outcome Measures
Name Time Method Tandem stance test 10 second Static balance was assessed using the tandem stance test. Patients were asked to maintain tandem stance position for 10 seconds without moving, with one foot's toe directly in front of the heel of the other foot. The test outcomes were recorded as either successful or unsuccessful. Participants unable to maintain the stance for the full 10 seconds were deemed unsuccessful, indicating an increased risk of falling.
Fracture Risk Assessment tool (FRAX) Baseline The fracture risk assessed with the FRAX tool (Fracture Risk Assessment tool). The clinical fracture risk factors of the patients were also questioned. The 10-year major osteoporotic and hip fracture risks of the patients were calculated by using the BMD (g/cm2) of the femoral neck.
Berg balance scale (BBS) Baseline Berg balance scale (BBS) was originally developed for the assessment of postural control, and is widely used in many areas of rehabilitation. There are 14 items in the scale, like commonly performing in daily activities sitting and standing balance, transfers, turning, and retrieving objects from the floor. BBS has high specificity and low sensitivity in patients at increased risk of falls. We used Turkish version of BBS whose reliability and validity in the Turkish language have been demonstrated.
Timed and go test (TUG) Baseline TUG is the shortest, simplest and probably the most reliable clinical balance test. There is a significant relationship between TUG times and functional mobility level. A recent systematic review showed that TUG is clinically applicable and reliable across multiple populations. In our study, patients were instructed to begin in a seated position, then stand up, walk a distance of three meters to cross a line on the ground, turn around, walk back, and sit down again. The time taken to complete this task was measured using a chronometer.
Tandem gait test Baseline Dynamic balance was evaluated using the tandem gait test. The patients were asked to take 10 consecutive steps with the toe of one toe and the heel of the other foot aligned. Patients who completed 10 serial steps were considered successful, while inability to complete the steps indicated an unsuccessful test.
Dual-energy x-ray absorptiometry measurements Baseline Bone density measurements were performed using the same DXA device for all participants (n =95) (Hologic QDR 4500SL (S/N 45624) (Bedford, MA). Osteoporosis was defined as a T-score of -2.5 SD or lower in any patient. The areal BMD (aBMD) (g/cm2) and T-score of the femoral neck (FN) and lumbar spine (LS) were used in the analyses.
Trial Locations
- Locations (1)
Istanbul University-Cerrahpasa
🇹🇷Istanbul, Turkey