Postmenopausal OsteoporosisNCT06502301
How Vertebral Fractures Effect Balance In Postmenopausal Women
An observational study of Postmenopausal Osteoporosis and Vertebral Fracture, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Postmenopausal Osteoporosis, Vertebral Fracture, Fracture of Vertebra
- What is being tested?
- Cross-sectional study
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- Patients aged 50 years or older
- Diagnosis of postmenopausal osteoporosis according to WHO (World Health Organization) criteria and/or osteoporotic vertebral fractures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34098
About this study
Official title: 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.
Read the 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.
- Being tested
- Cross-sectional study
- Keywords
- balance, computed static posturography, fall, FRAX, vertebral fracture
- Medical subject headings
- Osteoporosis, Postmenopausal, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-sectional studyOther
This is not intervention study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cross-sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Nov 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Okutan Kuzu, Istanbul University - Cerrahpasa
- Investigators
- Sansin Tuzun, Study director, Istanbul University - CerrahpasaDilara Okutan Kuzu, Principal investigator, Istanbul University - CerrahpasaRana Kaynar Terlemez, Study chair, Istanbul University - CerrahpasaDeniz Palamar Kadioglu, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502301
- Sponsor's protocol ID
- 89403766-604.01.02-136365
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25182228Sozen 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.
PubMed 28293453Wang 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.
PubMed 23640322Lems WF. Clinical relevance of vertebral fractures. Ann Rheum Dis. 2007 Jan;66(1):2-4. doi: 10.1136/ard.2006.058313.
PubMed 17178757Lynn 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.
PubMed 9084349Katzman 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.
PubMed 26782685Huang 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.
PubMed 16491290Huang 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.
PubMed 8944740Briggs 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.
PubMed 17206492Okutan D, Terlemez R, Palamar D, Tuzun S. How vertebral fractures effect balance in postmenopausal women. J Bodyw Mov Ther. 2025 Jun;42:109-114. doi: 10.1016/j.jbmt.2024.12.006. Epub 2024 Dec 10.
PubMed 40325641
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Balance With Computerized Posturography Device and Clinical Tests in Patients With Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT06502301
- Acronym / sponsor ID
- 89403766-604.01.02-136365
- Keywords
- balance, computed static posturography, fall, FRAX, vertebral fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women with vertebral fractures | – | Other: Cross-sectional studyThoracolumbar 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 | – | Other: Cross-sectional studyThoracolumbar 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged 50 years or older
- Diagnosis of postmenopausal osteoporosis according to WHO (World Health Organization) criteria and/or osteoporotic vertebral fractures
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-sectional studyThis is not intervention study. | Other | Postmenopausal women with vertebral fractures, Postmenopausal women without vertebral fractures |
Primary outcome
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.
6 secondary outcomes
Timed and go test (TUG)
Time frame: Baseline
Berg balance scale (BBS)
Time frame: Baseline
Tandem stance test
Time frame: 10 second
Tandem gait test
Time frame: Baseline
Fracture Risk Assessment tool (FRAX)
Time frame: Baseline
Dual-energy x-ray absorptiometry measurements
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 25182228Cosman 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.
- Background: PubMed 28293453Sozen 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.
- Background: PubMed 23640322Wang 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.
- Background: PubMed 17178757Lems WF. Clinical relevance of vertebral fractures. Ann Rheum Dis. 2007 Jan;66(1):2-4. doi: 10.1136/ard.2006.058313.
- Background: PubMed 9084349Lynn 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.
- Background: PubMed 26782685Katzman 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.
- Background: PubMed 16491290Huang 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.
- Background: PubMed 8944740Huang 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.
- Background: PubMed 17206492Briggs 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.
- Derived from this study: PubMed 40325641Okutan D, Terlemez R, Palamar D, Tuzun S. How vertebral fractures effect balance in postmenopausal women. J Bodyw Mov Ther. 2025 Jun;42:109-114. doi: 10.1016/j.jbmt.2024.12.006. Epub 2024 Dec 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sansin Tuzun study director
Istanbul University - Cerrahpasa
Dilara Okutan Kuzu principal investigator
Istanbul University - Cerrahpasa
Rana Kaynar Terlemez study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Osteoporosis and Vertebral Fracture, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computed static posturography (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06502301, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.