SarcopeniaNCT07238777
MRI-Based Paraspinal Fatty Degeneration and Its Association With BMD and Sarcopenia
An observational study of Sarcopenia, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional study aims to investigate the relationship between MRI-based paraspinal muscle fatty degeneration, bone mineral density (BMD), and sarcopenia parameters in postmenopausal women. A total of 100 participants aged 60-80 years will be included. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2025to 10 Jun 2025
- 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 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: postmenopausal women aged 60-80 years
Who may be able to join
- Female participants aged 60-80 years
- Postmenopausal status
- Lumbar MRI and DXA scan performed within the past six months
- Willingness to participate and ability to provide written informed consent
Who cannot join
- History of lumbar spine surgery (e.g., laminectomy, stabilization)
- Pfirrmann grade ≥4 lumbar disc degeneration on MRI¹³
- Secondary osteoporosis or Paget's disease
- Use of walking aids or mobility restrictions
- Neurological or systemic disorders affecting movement, including:
- Parkinson's disease
Show all 11Show fewer
- Stroke
- Amyotrophic lateral sclerosis (ALS)
- Central or peripheral vertigo
- Severe immobility or inability to complete performance tests
- Presence of a hip prosthesis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
About this study
Official title: Relationship of MRI-Based Paraspinal Fatty Degeneration With Bone Mineral Density and Sarcopenia Parameters
This cross-sectional study aims to investigate the relationship between MRI-based paraspinal muscle fatty degeneration, bone mineral density (BMD), and sarcopenia parameters in postmenopausal women. A total of 100 participants aged 60-80 years will be included. Lumbar paraspinal fatty infiltration will be evaluated both qualitatively using the Goutallier classification and quantitatively using ImageJ software to calculate muscle area, fat area, fat ratio, and functional muscle area.
BMD and T-scores of the lumbar spine (L1-L4) and femoral neck will be measured using dual-energy X-ray absorptiometry (DXA). Sarcopenia will be diagnosed based on EWGSOP2 criteria, including muscle mass (assessed by bioelectrical impedance analysis), handgrip strength, and physical performance tests (gait speed, SPPB, TUGT, and 5STS). Sarcopenia-specific quality of life will be assessed using the Sarcopenia Quality of Life Questionnaire (SarQoL-TR).
The study aims to clarify the associations among paraspinal muscle quality, bone health, and sarcopenia, providing a comprehensive understanding of muscle-bone interactions in postmenopausal women. Findings may support the use of paraspinal muscle evaluation as a complementary marker in the management of sarcopenia and osteoporosis.
- Conditions
- Sarcopenia
- Medical subject headings
- Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI-derived paraspinal fat ratio
Evaluation of the association between MRI-derived paraspinal fat ratio and lumbar (L1-L4) and femoral neck BMD values measured by DXA.
Measured: Baseline
Secondary outcomes (6)
Lumbar Bone Mineral Density (BMD)
Lumbar (L1-L4) BMD (g/cm²) measured using dual-energy X-ray absorptiometry (DXA).
Measured: Baseline
Lumbar T-Score
T-scores of L1-L4 vertebrae obtained from DXA scans.
Measured: Baseline
Femoral Neck BMD
BMD (g/cm²) and T-score values of the femoral neck measured by DXA.
Measured: Baseline
Femoral Neck T-Score
BMD (g/cm²) and T-score values of the femoral neck measured by DXA.
Measured: Baseline
Sarcopenia-Specific Quality of Life (SarQoL) Total Score
Quality of life specific to sarcopenia was assessed using the validated Turkish version of the Sarcopenia Quality of Life Questionnaire (SarQoL-TR). The questionnaire consists of 55 items across seven domains: physical and mental health, locomotion, body composition, functionality, activities of daily living, leisure activities, and fears. The total score ranges from 0 to 100, with higher scores indicating better quality of life and lower scores reflecting greater functional limitation and poorer health perception related to sarcopenia.
Measured: Baseline
Goutallier Index
The Goutallier classification was used to visually assess the degree of fatty degeneration in the lumbar paraspinal muscles (L1-L4) on axial MRI images. Each level was graded from 0 to 4, where Grade 0 indicates normal muscle without fat, and Grade 4 represents fat content greater than muscle tissue (>50%). Higher grades indicate greater fatty infiltration and poorer muscle quality.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start20 Apr 2025
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238777
- Sponsor's protocol ID
- Beylikdüzüstateh19
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of MRI-Based Paraspinal Fatty Degeneration With Bone Mineral Density and Sarcopenia Parameters
- ClinicalTrials.gov ID
- NCT07238777
- Acronym / sponsor ID
- Beylikdüzüstateh19
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 20 Nov 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.
This cross-sectional study aims to investigate the relationship between MRI-based paraspinal muscle fatty degeneration, bone mineral density (BMD), and sarcopenia parameters in postmenopausal women. A total of 100 participants aged 60-80 years will be included. Lumbar paraspinal fatty infiltration will be evaluated both qualitatively using the Goutallier classification and quantitatively using ImageJ software to calculate muscle area, fat area, fat ratio, and functional muscle area.
BMD and T-scores of the lumbar spine (L1-L4) and femoral neck will be measured using dual-energy X-ray absorptiometry (DXA). Sarcopenia will be diagnosed based on EWGSOP2 criteria, including muscle mass (assessed by bioelectrical impedance analysis), handgrip strength, and physical performance tests (gait speed, SPPB, TUGT, and 5STS). Sarcopenia-specific quality of life will be assessed using the Sarcopenia Quality of Life Questionnaire (SarQoL-TR).
The study aims to clarify the associations among paraspinal muscle quality, bone health, and sarcopenia, providing a comprehensive understanding of muscle-bone interactions in postmenopausal women. Findings may support the use of paraspinal muscle evaluation as a complementary marker in the management of sarcopenia and osteoporosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- postmenopausal women aged 60-80 years
Key inclusion criteria (4 listed)
- Female participants aged 60-80 years
- Postmenopausal status
- Lumbar MRI and DXA scan performed within the past six months
- Willingness to participate and ability to provide written informed consent
Key exclusion criteria (11 listed)
- History of lumbar spine surgery (e.g., laminectomy, stabilization)
- Pfirrmann grade ≥4 lumbar disc degeneration on MRI¹³
- Secondary osteoporosis or Paget's disease
- Use of walking aids or mobility restrictions
- Neurological or systemic disorders affecting movement, including:
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
MRI-derived paraspinal fat ratio
Time frame: Baseline
Evaluation of the association between MRI-derived paraspinal fat ratio and lumbar (L1-L4) and femoral neck BMD values measured by DXA.
6 secondary outcomes
Lumbar Bone Mineral Density (BMD)
Time frame: Baseline
Lumbar T-Score
Time frame: Baseline
Femoral Neck BMD
Time frame: Baseline
Femoral Neck T-Score
Time frame: Baseline
Sarcopenia-Specific Quality of Life (SarQoL) Total Score
Time frame: Baseline
Goutallier Index
Time frame: Baseline
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 20 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Beylikduzu State Hospital at 1 site 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 4 inclusion and 11 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
MRI-derived paraspinal fat ratio (time frame: Baseline). 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 20 Nov 2025.