NCT07238777

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (6)

  • Lumbar Bone Mineral Density (BMD)

    Baseline

  • Lumbar T-Score

    Baseline

  • Femoral Neck BMD

    Baseline

  • Femoral Neck T-Score

    Baseline

  • Sarcopenia-Specific Quality of Life (SarQoL) Total Score

    Baseline

  • +1 more secondary outcomes

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

postmenopausal women aged 60-80 years

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Stroke
  • Amyotrophic lateral sclerosis (ALS)
  • Central or peripheral vertigo
  • Severe immobility or inability to complete performance tests
  • Presence of a hip prosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

April 20, 2025

Primary Completion

June 10, 2025

Study Completion

June 10, 2025

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations