Recruiting NCT07677033

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

— Observational Osteoporosis Musculoskeletal Health Sarcopenia Osteopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Osteoporosis, Musculoskeletal Health, Sarcopenia, Osteopenia. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Turkey (Türkiye)
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Functional Muscle-Bone Incongruity Index (FKUI): Combined Evaluation of Handgrip Strength, Total Hip Bone Mineral Density, and Lumbar-Hip Bone Mineral Density Discordance in Adults Undergoing DXA

Overview

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.

Detailed description

This is a prospective, observational, single-center study evaluating adults undergoing routine DXA assessment in a Physical Medicine and Rehabilitation outpatient clinic. The study will investigate the clinical applicability of the Functional Muscle-Bone Incongruity Index (FKUI), a composite approach based on handgrip strength, total hip bone mineral density, and lumbar-hip bone mineral density discordance. No treatment or interventional procedure will be administered as part of the study. Handgrip strength will be measured using a calibrated hand dynamometer, and DXA-derived bone mineral density values will be recorded from routine clinical assessments. The study aims to determine whether the combined evaluation of muscle function and bone health parameters may provide a more comprehensive assessment of musculoskeletal status.

Primary outcome measures

Functional Muscle-Bone Incongruity Index (FKUI) [Time frame: Baseline (at study enrollment)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Turkey (Türkiye) · 1 center

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey — Küçükçekmece

Identifiers

NCT: NCT07677033 · FKUI · KSS-TRH-FKUI-2026

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗