How Vertebral Fractures Effect Balance In Postmenopausal Women
NCT Number: NCT06502301
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Postmenopausal Osteoporosis|Vertebral Fracture|Fracture of Vertebra|Fall
Interventions: OTHER: Cross-sectional study
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 95
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-11-01
Completion Date: 2021-02-28
Locations: Istanbul University-Cerrahpasa, Istanbul, 34098, Turkey

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.

Primary Outcome Measures: Computed static posturography, 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., Baseline
Secondary Outcome Measures: Timed and go test (TUG), 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., Baseline|Berg balance scale (BBS), 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., Baseline|Tandem stance test, 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., 10 second|Tandem gait test, 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., Baseline|Fracture Risk Assessment tool (FRAX), 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., Baseline|Dual-energy x-ray absorptiometry measurements, 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., Baseline