OsteoporosisNCT06645600
Balance and Muscle Strength as Indicators of Fracture Risk in Postmenopausal Women
An observational study of Osteoporosis, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study is designed as a cross-sectional clinical study. A total of 156 postmenopausal women who visited the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and have had Dual X-ray Absorptiometry (DXA) measurements taken within the last 6 months will be included. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Fracture risk
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2024to 15 Oct 2024
- How long will I take part?
- 1 Month
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: postmenopausal women
Who may be able to join
- Being a postmenopausal woman over the age of 50,
- Agreeing to participate in the study,
- Having no conditions that would prevent the individual from performing the tests to be administered during the study.
Who cannot join
- Refusal to participate,
- Presence of neuromuscular or cardiac diseases that would prevent the performance of the tests,
- Psychiatric disorders,
- Cognitive impairments,
- Uncontrolled hypertension,
- Use of medications that could affect the study results.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
About this study
Official title: Are Balance and Lower Extremity Muscle Strength Indicators of Fracture Risk Independently of Bone Mineral Density in Postmenopausal Women?: a Cross-sectional Study
The study is designed as a cross-sectional clinical study. A total of 156 postmenopausal women who visited the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and have had Dual X-ray Absorptiometry (DXA) measurements taken within the last 6 months will be included. The sociodemographic data of the patients will be recorded. Femoral neck and lumbar L1-L4 T-scores and femoral neck bone mineral density (BMD) values obtained from DXA measurements will be collected. To calculate fracture risk, the percentages for major and hip fracture risks will be calculated using the Fracture Risk Assessment Tool (FRAX®). The one-leg stance test, used to assess static posture and balance, and the 30-second sit-to-stand test, used to evaluate endurance and lower extremity strength, will be applied to the patients.
Read the detailed description
This study is designed as a cross-sectional clinical investigation aimed at assessing fracture risk in postmenopausal women. A total of 156 postmenopausal women who attended the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and had undergone Dual X-ray Absorptiometry (DXA) measurements within the past six months will be included. Sociodemographic data, such as age, weight, height, and medical history, will be recorded for each participant.
The study will gather femoral neck and lumbar L1-L4 T-scores, as well as femoral neck bone mineral density (BMD) values, obtained from DXA scans. To evaluate the risk of fractures, major and hip fracture percentages will be calculated using the Fracture Risk Assessment Tool (FRAX®), a widely accepted method for predicting fracture risk in osteoporosis patients.
Two functional tests will be applied: the one-leg stance test, which measures static balance and postural stability, and the 30-second sit-to-stand test, which assesses lower extremity strength and endurance. These simple, quick tests will be used to determine whether they can serve as practical predictors of fracture risk in postmenopausal patients. The study aims to evaluate whether these two functional tests can provide rapid and effective fracture risk assessments in clinical practice, offering a valuable tool for clinicians in identifying high-risk patients early and implementing preventive measures.
- Conditions
- Osteoporosis
- Being tested
- Fracture risk
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture riskDiagnostic test
To calculate fracture risk, the percentages for major and hip fracture risks will be calculated using the Fracture Risk Assessment Tool (FRAX®). The one-leg stance test, used to assess static posture and balance, and the 30-second sit-to-stand test, used to evaluate endurance and lower extremity strength, will be applied to the patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
The one-leg stance test score
The one-leg stance test is a simple and widely used balance assessment tool. During the test, the individual is asked to stand on one leg while maintaining balance for as long as possible without support. The test is typically performed with eyes open, and the duration for which the person can remain stable on one leg is recorded. It helps evaluate static balance and postural control, and poor performance on the test can be indicative of an increased risk of falls or fractures, particularly in older adults or those with musculoskeletal issues.
Measured: 0 day
The 30-second sit-to-stand test score
The 30-second sit-to-stand test is a functional assessment tool used to evaluate lower extremity muscle strength and endurance. During the test, the individual is asked to sit in a standard chair and then stand up and sit down as many times as possible within 30 seconds. The number of complete stands is recorded. This test is commonly used to assess functional mobility and leg strength, particularly in older adults or those with conditions affecting muscle function. It provides a quick and practical measure of lower body strength, which is important for daily activities and fall prevention.
Measured: 0 day
Secondary outcomes (1)
FRAX Hip and Major Fracture Risc
FRAX (Fracture Risk Assessment Tool) is a widely used algorithm developed by the World Health Organization (WHO) to estimate an individual's 10-year probability of experiencing a major osteoporotic fracture (hip, spine, forearm, or shoulder) and hip fracture specifically. It is designed to help clinicians assess fracture risk in patients, especially those with osteoporosis or low bone mineral density (BMD), and guide decisions regarding the need for interventions like pharmacological treatment.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start30 Sep 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
- Investigators
- Büşra Şirin Ahısha, MD, Principal investigator, Beylikdüzü State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645600
- Sponsor's protocol ID
- BeylikdüzüStateH3
- Status last verified
- Nov 2024
- First submitted
- 28 Sep 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Balance and Lower Extremity Muscle Strength Indicators of Fracture Risk Independently of Bone Mineral Density in Postmenopausal Women?: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06645600
- Acronym / sponsor ID
- BeylikdüzüStateH3
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 17 Oct 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.
The study is designed as a cross-sectional clinical study. A total of 156 postmenopausal women who visited the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and have had Dual X-ray Absorptiometry (DXA) measurements taken within the last 6 months will be included. The sociodemographic data of the patients will be recorded. Femoral neck and lumbar L1-L4 T-scores and femoral neck bone mineral density (BMD) values obtained from DXA measurements will be collected. To calculate fracture risk, the percentages for major and hip fracture risks will be calculated using the Fracture Risk Assessment Tool (FRAX®). The one-leg stance test, used to assess static posture and balance, and the 30-second sit-to-stand test, used to evaluate endurance and lower extremity strength, will be applied to the patients.
Detailed description
This study is designed as a cross-sectional clinical investigation aimed at assessing fracture risk in postmenopausal women. A total of 156 postmenopausal women who attended the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and had undergone Dual X-ray Absorptiometry (DXA) measurements within the past six months will be included. Sociodemographic data, such as age, weight, height, and medical history, will be recorded for each participant.
The study will gather femoral neck and lumbar L1-L4 T-scores, as well as femoral neck bone mineral density (BMD) values, obtained from DXA scans. To evaluate the risk of fractures, major and hip fracture percentages will be calculated using the Fracture Risk Assessment Tool (FRAX®), a widely accepted method for predicting fracture risk in osteoporosis patients.
Two functional tests will be applied: the one-leg stance test, which measures static balance and postural stability, and the 30-second sit-to-stand test, which assesses lower extremity strength and endurance. These simple, quick tests will be used to determine whether they can serve as practical predictors of fracture risk in postmenopausal patients. The study aims to evaluate whether these two functional tests can provide rapid and effective fracture risk assessments in clinical practice, offering a valuable tool for clinicians in identifying high-risk patients early and implementing preventive measures.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- postmenopausal women
Key inclusion criteria (3 listed)
- Being a postmenopausal woman over the age of 50,
- Agreeing to participate in the study,
- Having no conditions that would prevent the individual from performing the tests to be administered during the study.
Key exclusion criteria (6 listed)
- Refusal to participate,
- Presence of neuromuscular or cardiac diseases that would prevent the performance of the tests,
- Psychiatric disorders,
- Cognitive impairments,
- Uncontrolled hypertension,
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 |
|---|---|---|
| Fracture riskTo calculate fracture risk, the percentages for major and hip fracture risks will be calculated using the Fracture Risk Assessment Tool (FRAX®). The one-leg stance test, used to assess static posture and balance, and the 30-second sit-to-stand test, used to evaluate endurance and lower extremity strength, will be applied to the patients. | Diagnostic test | – |
Primary outcome
The one-leg stance test score
Time frame: 0 day
The one-leg stance test is a simple and widely used balance assessment tool. During the test, the individual is asked to stand on one leg while maintaining balance for as long as possible without support. The test is typically performed with eyes open, and the duration for which the person can remain stable on one leg is recorded. It helps evaluate static balance and postural control, and poor performance on the test can be indicative of an increased risk of falls or fractures, particularly in older adults or those with musculoskeletal issues.
The 30-second sit-to-stand test score
Time frame: 0 day
The 30-second sit-to-stand test is a functional assessment tool used to evaluate lower extremity muscle strength and endurance. During the test, the individual is asked to sit in a standard chair and then stand up and sit down as many times as possible within 30 seconds. The number of complete stands is recorded. This test is commonly used to assess functional mobility and leg strength, particularly in older adults or those with conditions affecting muscle function. It provides a quick and practical measure of lower body strength, which is important for daily activities and fall prevention.
1 secondary outcome
FRAX Hip and Major Fracture Risc
Time frame: 0 day
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 5 Nov 2024.
- 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.
Büşra Şirin Ahısha, MD principal investigator
Beylikdüzü State Hospital
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 Osteoporosis, run by Beylikduzu State Hospital 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 3 inclusion and 6 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 5 Nov 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?
The one-leg stance test score (time frame: 0 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2024.