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CompletedNCT06760598Updated Jan 8, 2025

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

An observational study in Osteoporosis, Sarcopenia and Ultrasonography, sponsored by Istanbul University - Cerrahpasa. Completed at 2 sites in Turkey (Türkiye). Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by Istanbul University - Cerrahpasa · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
103
Ages
50 Years and older
Sex
Female
01

Study 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.

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).

02

Conditions studied

  • Osteoporosis
  • Sarcopenia
  • Ultrasonography
  • Hyperkyphosis

Keywords

  • muscle thickness
  • sarcopenia
  • hyperkyphosis
  • ultrasonography
03

In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's enrollment of 103 is below the median of 180 across 461 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 693 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
103 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. tandem stance and gait test

    static and dynamic balance was measured.

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

  2. 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.

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

  3. Timed up and go test

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

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

  4. chair stand test

    The five times CST evaluates the strength, power, and endurance of the lower extremity muscle group, particularly the quadriceps femoris muscle

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

  5. quadriceps femoris muscle thickness

    evaluated by ultrasound

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

  6. 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)

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

07

Study locations

2 sites
  • Istanbul University Cerrahpasa
    Istanbul, Istanbul 59030, Turkey (Türkiye)
  • Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty
    Istanbul, SÜLEYMANPAŞA 59030, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: 12 months after publication of primary results

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06760598
Responsible party
Eslem Peker Belene (Medical Doctor, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Jan 7, 2025
Start date
Jul 1, 2022
Primary completion
Dec 31, 2022
Completion
Nov 29, 2023
Last update
Jan 8, 2025

Study contacts

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
OSMAN AYKAN KARGIN
study chair · Istanbul University- Cerrahpasa, Cerrahpasa Medical Faculty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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