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Completed

NCT Number: NCT06645600

Balance and Muscle Strength as Indicators of Fracture Risk in Postmenopausal Women

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fracture risk

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. FRAX Hip and Major Fracture Risc

    Time frame: 0 day

    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.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Are Balance and Lower Extremity Muscle Strength Indicators of Fracture Risk Independently of Bone Mineral Density in Postmenopausal Women?: a Cross-sectional Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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