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

Evaluation of the Relationship Between Thoracic Kyphosis and Quadriceps Muscle Thickness with Balance and Fall Risk in Women with Postmenopausal Osteoporosis

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia; Osteoporosis; Ultrasonography; Hyperkyphosis

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 59030
    • İstanbul University Cerrahpaşa
  • Süleymanpaşa
    • Istanbul, Süleymanpaşa, Turkey, 59030
      • Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 50 years and over with postmenopausal osteoporosis and/or osteoporotic vertebral fractures according to WHO criteria who applied to the outpatient clinic of the Department of Physical Medicine and Rehabilitation, Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tandem stance and gait test	static and dynamic balance was measured.	Data were collected over a single measurement period of 6 months.
Timed up and go test	There is a significant relationship between TUG times and functional mobility level	Data were collected over a single measurement period of 6 months.
chair stand test	The five times CST evaluates the strength, power, and endurance of the lower extremity muscle group, particularly the quadriceps femoris muscle	Data were collected over a single measurement period of 6 months.
quadriceps femoris muscle thickness	evaluated by ultrasound	Data were collected over a single measurement period of 6 months.
thoracic kyphosis	The lateral thoracic vertebra radiographs were taken while standing position, the Cobb angle was automatically obtained by computer-aided method by marking the parallel lines drawn from the upper edge of the upper thoracic vertebra (T4), and the lower edge of the lower thoracic vertebra (T12)	Data were collected over a single measurement period of 6 months.
berg balance scale	Berg balance scale was originally developed for the assessment of postural control and is widely used in many areas of rehabilitation. There are 14 items in the scale, like commonly performing in daily activities sitting and standing balance, transfers, turning, and retrieving objects from the floor. The highest total score is 56 points. If the patient scores between 0-20 points, they are considered wheelchair dependent, between 21-40 points they can walk with assistance and between 41-56 points they are considered independent in mobilization activities.	Data were collected over a single measurement period of 6 months.

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Principal Investigator: ESLEM PEKER BELENE, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty; Study Director: ZEYNEP ÜLKÜ AKARIRMAK, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty; Study Chair: RANA TERLEMEZ, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty; Study Chair: OSMAN AYKAN KARGIN, Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: sarcopenia; ultrasonography; muscle thickness; hyperkyphosis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Metabolic Diseases; Spinal Diseases; Bone Diseases, Metabolic; Muscular Atrophy; Atrophy; Spinal Curvatures; Osteoporosis; Sarcopenia; Osteoporosis, Postmenopausal; Kyphosis
• Other Study ID Numbers: E-83045809-604.01.01-439462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: 12 months after publication of primary results
• IPD Sharing Access Criteria: Academic and Clinical Researchers, Regulatory Authorities and Non-commercial Researchers and Public Health Organizations can access the data Demographic and Clinical Data, Outcome Measures,Study protocols, statistical analysis plans, and publications can be accessed Submit a Request, Approval Process, Secure Access will be accessed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No