How Vertebral Fractures Effect Balance In Postmenopausal Women

July 13, 2024 updated by: Dilara Okutan Kuzu, Istanbul University - Cerrahpasa (IUC)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34098
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Postmenopausal women with vertebral fractures
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.
Other: Cross-sectional study
This is not intervention study.
Postmenopausal women without vertebral fractures
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.
Other: Cross-sectional study
This is not intervention study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed and go test (TUG)
Time Frame: 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.
Baseline
Berg balance scale (BBS)
Time Frame: 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.
Baseline
Tandem stance test
Time Frame: 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.
10 second
Tandem gait test
Time Frame: 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.
Baseline
Fracture Risk Assessment tool (FRAX)
Time Frame: 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.
Baseline
Dual-energy x-ray absorptiometry measurements
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Chair: Deniz Palamar Kadioglu, Istanbul University - Cerrahpasa (IUC)
  • Study Director: Sansin Tuzun, Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: Dilara Okutan Kuzu, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: Rana Kaynar Terlemez, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 13, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 89403766-604.01.02-136365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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