OsteoporosisNCT06760598
Evaluation of Balance and Functionality in Postmenopausal Osteoporosis Using Quadriceps Femoris Muscle Thickness, Beyond Thoracic Hyperkyphosis
An observational study of Osteoporosis and Sarcopenia, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis, Sarcopenia, Ultrasonography
- How many people
- 103 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 29 Nov 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University Cerrahpasa
Istanbul, Istanbul, 59030
Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, SÜLEYMANPAŞA, 59030
About this study
Official title: 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.
Read the 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).
- Conditions
- Osteoporosis, Sarcopenia, Ultrasonography, Hyperkyphosis
- Keywords
- muscle thickness, sarcopenia, hyperkyphosis, ultrasonography
- Medical subject headings
- Osteoporosis, Sarcopenia, Kyphosis
What is being measured
The primary outcome is the main question the study is designed to answer.
tandem stance and gait test
static and dynamic balance was measured.
Measured: 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.
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
Measured: 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
Measured: Data were collected over a single measurement period of 6 months.
quadriceps femoris muscle thickness
evaluated by ultrasound
Measured: 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)
Measured: Data were collected over a single measurement period of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jul 2022
- Primary completion31 Dec 2022
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslem Peker Belene, Istanbul University - Cerrahpasa
- Investigators
- ESLEM PEKER BELENE, Principal investigator, Istanbul University-Cerrahpasa, Cerrahpasa Medical FacultyZEYNEP ÜLKÜ AKARIRMAK, Study director, Istanbul University-Cerrahpasa, Cerrahpasa Medical FacultyRANA TERLEMEZ, Study chair, Istanbul University-Cerrahpasa, Cerrahpasa Medical FacultyOSMAN AYKAN KARGIN, Study chair, Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760598
- Sponsor's protocol ID
- E-83045809-604.01.01-439462
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Thoracic Kyphosis and Quadriceps Muscle Thickness with Balance and Fall Risk in Women with Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT06760598
- Acronym / sponsor ID
- E-83045809-604.01.01-439462
- Conditions
- Osteoporosis, Sarcopenia, Ultrasonography, Hyperkyphosis
- Keywords
- muscle thickness, sarcopenia, hyperkyphosis, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tandem stance and gait test
Time frame: Data were collected over a single measurement period of 6 months.
static and dynamic balance was measured.
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.
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
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
quadriceps femoris muscle thickness
Time frame: Data were collected over a single measurement period of 6 months.
evaluated by ultrasound
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ESLEM PEKER BELENE principal investigator
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
ZEYNEP ÜLKÜ AKARIRMAK study director
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
RANA TERLEMEZ study chair
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Sarcopenia, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tandem stance and gait test (time frame: Data were collected over a single measurement period of 6 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.