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NCT Number: NCT07238777

MRI-Based Paraspinal Fatty Degeneration and Its Association With BMD and Sarcopenia

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Lumbar Bone Mineral Density (BMD)

    Time frame: Baseline

    Lumbar (L1-L4) BMD (g/cm²) measured using dual-energy X-ray absorptiometry (DXA).

  2. Lumbar T-Score

    Time frame: Baseline

    T-scores of L1-L4 vertebrae obtained from DXA scans.

  3. Femoral Neck BMD

    Time frame: Baseline

    BMD (g/cm²) and T-score values of the femoral neck measured by DXA.

  4. Femoral Neck T-Score

    Time frame: Baseline

    BMD (g/cm²) and T-score values of the femoral neck measured by DXA.

  5. Sarcopenia-Specific Quality of Life (SarQoL) Total Score

    Time frame: Baseline

    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.

  6. Goutallier Index

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Relationship of MRI-Based Paraspinal Fatty Degeneration With Bone Mineral Density and Sarcopenia Parameters

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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