Clinical trial NCT06645600: Balance and Muscle Strength as Indicators of Fracture Risk in Postmenopausal Women
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 156
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: postmenopausal women

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The one-leg stance test score
timeFrame: 0 day
measure: The 30-second sit-to-stand test score
timeFrame: 0 day
Secondary outcomes:
measure: FRAX Hip and Major Fracture Risc
timeFrame: 0 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
state: Beylikdüzü
Study officials:
affiliation: Beylikdüzü State Hospital
name: Büşra Şirin Ahısha, MD
role: PRINCIPAL_INVESTIGATOR
References: