OsteoporosisFKUINCT07677033
Functional Muscle-Bone Incongruity Index (FKUI): A Prospective Observational Study
An observational study of Osteoporosis and Musculoskeletal Health, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Musculoskeletal Health, Sarcopenia
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
Küçükçekmece, Istanbul, 34303
Dilek Ün Oğuzhanasiltürk, MD, +905056367184, dilekunoguzhan@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Osteoporosis, Musculoskeletal Health, Sarcopenia, Osteopenia
- Keywords
- Functional Muscle-Bone Incongruity Index FKUI, FKUI, Bone Mineral Density, Hip-Spine Discordance, Handgrip Strength
- Medical subject headings
- Osteoporosis, Sarcopenia, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677033
- Sponsor's protocol ID
- FKUI
- Other IDs
- KSS-TRH-FKUI-2026
- Acronym
- FKUI
- Status last verified
- May 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan has been established to share individual participant data. Participant confidentiality will be maintained in accordance with ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07677033
- Acronym / sponsor ID
- FKUI / FKUI
- Conditions
- Osteoporosis, Musculoskeletal Health, Sarcopenia, Osteopenia
- Keywords
- Functional Muscle-Bone Incongruity Index FKUI, FKUI, Bone Mineral Density, Hip-Spine Discordance, Handgrip Strength
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 30 Jun 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
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
Functional Muscle-Bone Incongruity Index (FKUI)
Time frame: Baseline (at study enrollment)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. No plan has been established to share individual participant data. Participant confidentiality will be maintained in accordance with ethical and institutional requirements.
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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.
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 Osteoporosis and Musculoskeletal Health, run by Kanuni Sultan Suleyman Training and Research 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek Ün Oğuzhanasiltürk, MD (+90 5056367184, dilekunoguzhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Muscle-Bone Incongruity Index (FKUI) (time frame: Baseline (at study enrollment)). 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 30 Jun 2026.