NCT06645600

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

15 days

First QC Date

September 28, 2024

Last Update Submit

November 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    0 day

Secondary Outcomes (1)

  • FRAX Hip and Major Fracture Risc

    0 day

Interventions

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.

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

postmenopausal women

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Büşra Şirin Ahısha, MD

    Beylikdüzü State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2024

First Posted

October 17, 2024

Study Start

September 30, 2024

Primary Completion

October 15, 2024

Study Completion

October 15, 2024

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations