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

Completed

• Conditions: Osteoporosis; Sarcopenia; Ultrasonography; Hyperkyphosis

• Registration Number: NCT06760598
• Lead Sponsor: Istanbul University - Cerrahpasa

Brief Summary

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

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 Timeline

• Study Start: 2022-07-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-11-29
• Study First Submitted: 2024-12-27
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tandem stance and gait test	Data were collected over a single measurement period of 6 months.	static and dynamic balance was measured.
berg balance scale	Data were collected over a single measurement period of 6 months.	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.
Timed up and go test	Data were collected over a single measurement period of 6 months.	There is a significant relationship between TUG times and functional mobility level
chair stand test	Data were collected over a single measurement period of 6 months.	The five times CST evaluates the strength, power, and endurance of the lower extremity muscle group, particularly the quadriceps femoris muscle
quadriceps femoris muscle thickness	Data were collected over a single measurement period of 6 months.	evaluated by ultrasound
thoracic kyphosis	Data were collected over a single measurement period of 6 months.	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)

Trial Locations

Locations (2)

Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Süleymanpaşa, Turkey

Istanbul University Cerrahpasa; 🇹🇷 Istanbul, Turkey