Evaluation of Balance and Functionality in Postmenopausal Osteoporosis Using Quadriceps Femoris Muscle Thickness, Beyond Thoracic Hyperkyphosis

NCT ID: NCT06760598

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-11-29

Brief Summary

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To determine the impact of thoracic hyperkyphosis, sarcopenia and quadriceps muscle thickness evaluated by ultrasonography (USG) on balance, fall risk and functional parameters in women with postmenopausal osteoporosis, to assess their interrelationships and to compare the clinical characteristics of sarcopenia and thoracic hyperkyphosis.

Detailed Description

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An observational study was conducted on patients with PMO and/or osteoporotic vertebral fractures according to WHO criteria. One hundred seventeen patients who were 50 years of age or older, with a diagnosis of PMO and/or osteoporotic vertebral fractures according to WHO criteria, who were able to ambulate without any assistive devices were included in the study. Patients with a history of neurological disease which may affect balance and proprioception, visual and vestibular disease, previous major lower extremity surgery or previous vertebra surgery were excluded. The investigators also excluded the patients with advanced heart, liver, or renal failure, stage 4 knee osteoarthritis, psychiatric disorders, and use of any medication affecting the central nervous system.

Age, height, weight, body mass index (BMI), comorbidities, medications, previous surgeries, steroid use, previous fractures and the energy level of these fractures (low or high), fracture location, family history of fractures, alcohol use, smoking, menopausal age and the number of falls in a year were questioned. The FRAX algorithm was used to determine the risk of fracture.

The Cobb angle of thoracic kyphosis was calculated radiographically and QFM thickness was measured from anterior thigh via ultrasonography (USG). The presence of sarcopenia was determined. Balance, fall risk and physical function were evaluated with tandem stance and gait test, Berg balance scale (BBS), Timed up and go test (TUG), hand grip strength, chair stand test (CST).

Conditions

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Osteoporosis Sarcopenia Ultrasonography Hyperkyphosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Patient who were 50 years of age or older, had postmenopausal osteoporosis and/or osteoporotic vertebral fractures according to WHO criteria,
* Patient who were able to ambulate without any assistive devices

Exclusion Criteria

* History of neurological disease which may affect balance and proprioception,
* Visual and vestibular disease
* Previous major lower extremity surgery or previous vertebra surgery
* Advanced heart, liver, or renal failure
* Stage 4 knee osteoarthritis
* Psychiatric disorders
* Use of any medication affecting the central nervous system.
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Eslem Peker Belene

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ESLEM PEKER BELENE

Role: PRINCIPAL_INVESTIGATOR

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

ZEYNEP ÜLKÜ AKARIRMAK

Role: STUDY_DIRECTOR

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

RANA TERLEMEZ

Role: STUDY_CHAIR

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

OSMAN AYKAN KARGIN

Role: STUDY_CHAIR

Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty

Locations

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Istanbul University Cerrahpasa

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty

Istanbul, SÜLEYMANPAŞA, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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E-83045809-604.01.01-439462

Identifier Type: -

Identifier Source: org_study_id

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