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

November 2, 2024 updated by: Busra Sirin, Beylikduzu State Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beylikdüzü
      • Istanbul, Beylikdüzü, Turkey, 34147
        • Beylikduzu State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

postmenopausal women

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 day
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.
0 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Büşra Şirin Ahısha, MD, Beylikduzu State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2024

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

September 28, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 2, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • BeylikdüzüStateH3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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