Clinical trial NCT06760598: Evaluation of Balance and Functionality in Postmenopausal Osteoporosis Using Quadriceps Femoris Muscle Thickness, Beyond Thoracic Hyperkyphosis
Official title: Evaluation of the Relationship Between Thoracic Kyphosis and Quadriceps Muscle Thickness with Balance and Fall Risk in Women with Postmenopausal Osteoporosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Sarcopenia
Ultrasonography
Hyperkyphosis
Keywords: muscle thickness
sarcopenia
hyperkyphosis
ultrasonography
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 103
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: tandem stance and gait test
timeFrame: Data were collected over a single measurement period of 6 months.
measure: berg balance scale
timeFrame: Data were collected over a single measurement period of 6 months.
measure: Timed up and go test
timeFrame: Data were collected over a single measurement period of 6 months.
measure: chair stand test
timeFrame: Data were collected over a single measurement period of 6 months.
measure: quadriceps femoris muscle thickness
timeFrame: Data were collected over a single measurement period of 6 months.
measure: thoracic kyphosis
timeFrame: Data were collected over a single measurement period of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty
state: Süleymanpaşa
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
affiliation: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
name: ESLEM PEKER BELENE
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
name: ZEYNEP ÜLKÜ AKARIRMAK
role: STUDY_DIRECTOR
affiliation: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
name: RANA TERLEMEZ
role: STUDY_CHAIR
affiliation: Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty
name: OSMAN AYKAN KARGIN
role: STUDY_CHAIR
References: