Functional Muscle-Bone Incongruity Index (FKUI): A Prospective Observational Study

NCT07677033 | Recruiting

• 2 other identifiers: FKUIKSS-TRH-FKUI-2026
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The Functional Muscle-Bone Incongruity Index (FKUI) is a novel approach developed to evaluate the relationship between muscle function and bone health. This prospective observational study aims to investigate the clinical applicability of FKUI, which combines handgrip strength, total hip bone mineral density (BMD), and lumbar-hip BMD discordance. Approximately 200 adult participants undergoing routine DXA assessment will be enrolled. The study will examine whether the combined evaluation of muscle function and bone health parameters provides a more comprehensive assessment of musculoskeletal status than individual measures alone.

Conditions

Osteoporosis; Musculoskeletal Health; Sarcopenia; Osteopenia

Keywords

Functional Muscle-Bone Incongruity Index FKUI; FKUI; Bone Mineral Density; Hip-Spine Discordance; Handgrip Strength

Outcome Measures

Primary Outcomes (1)

• Functional Muscle-Bone Incongruity Index (FKUI)

  Assessment of the clinical applicability of the Functional Muscle-Bone Incongruity Index (FKUI), a composite index based on handgrip strength, total hip bone mineral density, and lumbar-hip bone mineral density discordance.

  Baseline (at study enrollment)

Study Arms (1)

Adults Undergoing Bone Mineral Density Evaluation

Adult patients attending the Physical Medicine and Rehabilitation outpatient clinic and undergoing routine DXA assessment as part of clinical evaluation. Participants will undergo handgrip strength measurement and assessment of bone mineral density parameters. The Functional Muscle-Bone Incongruity Index (FKUI) will be evaluated using handgrip strength, total hip bone mineral density, and lumbar-hip bone mineral density discordance. No treatment or interventional procedure will be administered.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults aged 18 years and older attending the Physical Medicine and Rehabilitation outpatient clinic who are scheduled to undergo routine dual-energy X-ray absorptiometry (DXA) assessment as part of their clinical evaluation. Participants will be recruited consecutively from routine clinical practice. The study aims to evaluate the relationship between muscle function and bone health through the Functional Muscle-Bone Incongruity Index (FKUI), which incorporates handgrip strength, total hip bone mineral density, and lumbar-hip bone mineral density discordance.

You may qualify if:

• Age 18 years or older
• Attendance at the Physical Medicine and Rehabilitation outpatient clinic
• Scheduled to undergo routine bone mineral density assessment by DXA as part of clinical evaluation
• Ability to perform handgrip strength testing
• Availability of lumbar spine and total hip bone mineral density measurements suitable for analysis
• Ability and willingness to provide written informed consent

You may not qualify if:

• Age younger than 18 years
• Secondary causes of osteoporosis (e.g., hyperparathyroidism, Cushing syndrome, malignancy, or other conditions affecting bone metabolism)
• History of metabolic bone disease
• Major trauma or fracture within the previous 6 months
• Upper extremity disorders that may significantly affect handgrip strength measurement (e.g., severe osteoarthritis, neurological disorders, major deformities)
• DXA measurements that are technically inadequate or unsuitable for analysis
• Refusal or inability to provide written informed consent

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey

Küçükçekmece, Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Sarcopenia; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Dilek Ün Oğuzhanasiltürk, MD

CONTACT

+90 5056367184; dilekunoguzhan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)