Skip to main content
OpenTrials
Completed

NCT Number: NCT06760598

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Atrophy Bone Diseases Bone Diseases, Metabolic Hyperkyphosis Kyphosis Metabolic Diseases Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Spinal Curvatures Spinal Diseases Ultrasonography

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Istanbul University Cerrahpasa, Istanbul, Turkey (Türkiye)

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. tandem stance and gait test

    Time frame: Data were collected over a single measurement period of 6 months.

    static and dynamic balance was measured.

  2. berg balance scale

    Time frame: 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.

  3. Timed up and go test

    Time frame: Data were collected over a single measurement period of 6 months.

    There is a significant relationship between TUG times and functional mobility level

  4. chair stand test

    Time frame: 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

  5. quadriceps femoris muscle thickness

    Time frame: Data were collected over a single measurement period of 6 months.

    evaluated by ultrasound

  6. thoracic kyphosis

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 7, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.