- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06645600
Balance and Muscle Strength as Indicators of Fracture Risk in Postmenopausal Women
Are Balance and Lower Extremity Muscle Strength Indicators of Fracture Risk Independently of Bone Mineral Density in Postmenopausal Women?: a Cross-sectional Study
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beylikdüzü
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Istanbul, Beylikdüzü, Turkey, 34147
- Beylikduzu State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The one-leg stance test score
Time Frame: 0 day
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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.
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0 day
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The 30-second sit-to-stand test score
Time Frame: 0 day
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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.
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0 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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FRAX Hip and Major Fracture Risc
Time Frame: 0 day
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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.
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0 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Büşra Şirin Ahısha, MD, Beylikduzu State Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BeylikdüzüStateH3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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