How Vertebral Fractures Effect Balance In Postmenopausal Women

NCT06502301 | Completed

• 1 other identifier: 89403766-604.01.02-136365
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Osteoporosis; Vertebral Fracture; Fracture of Vertebra; Fall

Keywords

balance; computed static posturography; fall; FRAX; vertebral fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Timed and go test (TUG)

  Baseline

• Berg balance scale (BBS)

  Baseline

• Tandem stance test

  10 second

• Tandem gait test

  Baseline

• Fracture Risk Assessment tool (FRAX)

  Baseline

Study Arms (2)

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

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

Interventions

Cross-sectional study OTHER

This is not intervention study.

Postmenopausal women with vertebral fractures; Postmenopausal women without vertebral fractures

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (9)

• Cosman F, de Beur SJ, LeBoff MS, Lewiecki EM, Tanner B, Randall S, Lindsay R; National Osteoporosis Foundation. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15.

  PMID: 25182228 BACKGROUND

• Sozen T, Ozisik L, Basaran NC. An overview and management of osteoporosis. Eur J Rheumatol. 2017 Mar;4(1):46-56. doi: 10.5152/eurjrheum.2016.048. Epub 2016 Dec 30.

  PMID: 28293453 BACKGROUND

• Wang LY, Liaw MY, Huang YC, Lau YC, Leong CP, Pong YP, Chen CL. Static and dynamic balance performance in patients with osteoporotic vertebral compression fracture. J Back Musculoskelet Rehabil. 2013;26(2):199-205. doi: 10.3233/BMR-130369.

  PMID: 23640322 BACKGROUND

• Lems WF. Clinical relevance of vertebral fractures. Ann Rheum Dis. 2007 Jan;66(1):2-4. doi: 10.1136/ard.2006.058313.

  PMID: 17178757 BACKGROUND

• Lynn SG, Sinaki M, Westerlind KC. Balance characteristics of persons with osteoporosis. Arch Phys Med Rehabil. 1997 Mar;78(3):273-7. doi: 10.1016/s0003-9993(97)90033-2.

  PMID: 9084349 BACKGROUND

• Katzman WB, Vittinghoff E, Kado DM, Lane NE, Ensrud KE, Shipp K. Thoracic kyphosis and rate of incident vertebral fractures: the Fracture Intervention Trial. Osteoporos Int. 2016 Mar;27(3):899-903. doi: 10.1007/s00198-015-3478-2. Epub 2016 Jan 18.

  PMID: 26782685 BACKGROUND

• Huang MH, Barrett-Connor E, Greendale GA, Kado DM. Hyperkyphotic posture and risk of future osteoporotic fractures: the Rancho Bernardo study. J Bone Miner Res. 2006 Mar;21(3):419-23. doi: 10.1359/JBMR.051201. Epub 2005 Dec 5.

  PMID: 16491290 BACKGROUND

• Huang C, Ross PD, Wasnich RD. Vertebral fracture and other predictors of physical impairment and health care utilization. Arch Intern Med. 1996 Nov 25;156(21):2469-75.

  PMID: 8944740 BACKGROUND

• Briggs AM, Greig AM, Wark JD. The vertebral fracture cascade in osteoporosis: a review of aetiopathogenesis. Osteoporos Int. 2007 May;18(5):575-84. doi: 10.1007/s00198-006-0304-x. Epub 2007 Jan 6.

  PMID: 17206492 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Spinal Fractures

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sansin Tuzun

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Dilara Okutan Kuzu

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Rana Kaynar Terlemez

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Deniz Palamar Kadioglu

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: November 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)