OsteosarcopeniaOsteosarcopeniNCT07910201
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
An observational study of Osteosarcopenia and Sarcopenia, run by Ayşe Ukbe Baykut at 1 site in Turkey (Türkiye).
Trial summary
Osteosarcopenia (OSP) is defined as the coexistence of sarcopenia and osteoporosis/osteopenia. There is an intense and complex interaction-both mechanical (the "mechanostat" hypothesis) and biochemical (involving factors such as estrogen, testosterone, GH, IGF-1, IL-6, and osteocalcin)-between osteoporosis and… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Osteosarcopenia, Sarcopenia, Postmenopausal Osteoporosis
- What is being tested?
- Dual-energy x-ray absorptiometer
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 17 Nov 2026
- 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with osteoporosis who present to a tertiary care center and meet the inclusion and exclusion criteria will be enrolled in sequential order.
Who may be able to join
- Possessing mental and physical competence
- Being a postmenopausal woman
- Being independently ambulatory
- Diagnosed with primary osteoporosis
Who cannot join
- Infection
- Pacemaker
- Peripheral circulatory disorder
- Known concomitant malignancy or end-stage organ failure
- Known concomitant central and/or peripheral nervous system disease
- Coagulopathy
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- Difficulty walking that could affect the assessment of physical performance
- Inflammatory arthritis
- Metabolic bone disease
- Secondary osteoporosis
- Malabsorption syndromes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, çankaya, 06800
About this study
Osteosarcopenia (OSP) is defined as the coexistence of sarcopenia and osteoporosis/osteopenia. There is an intense and complex interaction-both mechanical (the "mechanostat" hypothesis) and biochemical (involving factors such as estrogen, testosterone, GH, IGF-1, IL-6, and osteocalcin)-between osteoporosis and sarcopenia. The general consensus is that sarcopenia leads to a reduction in bone mineral density. OSP is associated with significant physical disability, which poses a major threat to the future loss of independence. The increased propensity for falls-a consequence of sarcopenia-compounds the risk of fractures associated with osteoporosis, further exacerbating adverse health outcomes. Kinesiophobia, or the "fear of movement," is an excessive and irrational dread of performing physical movements or activities, stemming from the fear of a painful injury or the possibility of re-injury; this often leads to restrictions in activities of daily living. In a clinical setting, kinesiophobia is a critical issue that must be addressed to effectively manage a patient's disability, as it directly influences rehabilitation strategies. While there is some limited literature exploring the individual associations of osteoporosis and sarcopenia with kinesiophobia, no research has yet examined the relationship between osteosarcopenia and kinesiophobia. Our study aims to determine the impact of osteosarcopenia on kinesiophobia and quality of life in postmenopausal women.
- Being tested
- Dual-energy x-ray absorptiometer
- Keywords
- osteosarcopenia, sarcopenia, postmenopausal osteoporosis, kinesiophobia, fear of falling
- Medical subject headings
- Sarcopenia, Osteoporosis, Postmenopausal, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy x-ray absorptiometerOther
L1-L4 and L2-L4 regions, femoral neck T-scores, femoral neck BMD values, and body fat-muscle distribution will be evaluated. For appendicular skeletal muscle mass (ASM), the lean mass of the four extremities will be summed; an ASM value of <15 kg will be considered indicative of sarcopenia. ASM will be adjusted for body size (ASM/height² and ASM/BMI).
| Study group | Role | What they receive |
|---|---|---|
| osteosarcopenia | Not described Receives: Other: Dual-energy x-ray absorptiometer | |
| osteoporosis | Not described Receives: Other: Dual-energy x-ray absorptiometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale for Kinesiophobia
The Tampa Scale for Kinesiophobia will be used to assess the fear of movement in patients. The scale consists of 17 items, with each item scored on a scale from 1 to 4. The minimum score that can be obtained is 17, and the maximum score is 68. In the studies, a score of 37 or higher has been defined as kinesiophobia.
Measured: baseline
International Falls Efficacy Scale
The level of concern regarding falling will be assessed using the International Falls Efficacy Scale . The scale consists of 16 items, with each item scored on a scale from 1 to 4. The minimum possible score is 16 and the maximum is 64; a score of ≤19 indicates a low fear of falling, while a score of ≥28 indicates a high fear of falling.
Measured: baseline
Short Form-36 Health Survey (SF-36)
The Short Form-36 Health Survey will be used to assess quality of life. It is a scale consisting of 8 subdimensions and a total of 36 items. The scoring ranges from 0 to 100, with higher scores indicating a better quality of life.
Measured: baseline
Secondary outcomes (5)
Grip strength
A Baseline hydraulic hand dynamometer (INC., White Plains, NY 10602, U.S.A.) will be used to measure grip strength. Grip strength will be assessed three times for each hand while the individual is seated in a chair, and the highest value obtained will be recorded.
Measured: baseline
Fracture Risk Assessment Tool
The Fracture Risk Assessment Tool will be used to estimate the 10-year probability of fractures, specifically calculating the risk for major osteoporotic fractures and hip fractures.
Measured: baseline
calf circumference
For the calf circumference measurement, the measurement should be taken at the widest part of the calf while standing.
Measured: baseline
gait speed test
For the gait speed test, patients will be asked to walk at a normal pace along a flat surface over a distance of 4 meters-from a designated starting point to an end point-while the time taken is measured using a stopwatch; the gait speed will then be calculated.
Measured: baseline
Chair sit-to-stand test
In the sit-to-stand test, the time required for patients to stand up and sit down five times while seated on a chair without armrests will be recorded. This will be performed twice, and the fastest time measured will be recorded.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start2 Jan 2025
- Primary completion10 Nov 2026 (estimated)
- Study completion17 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcopeniaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşe Ukbe Baykut
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Bilkent Sehir Hastanesi
- Responsible party
- Sponsor-investigator, Ayşe Ukbe Baykut, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910201
- Sponsor's protocol ID
- ACHBİLKENTAUBAYKUT007
- Acronym
- Osteosarcopeni
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly, due to participant privacy and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07910201
- Acronym / sponsor ID
- Osteosarcopeni / ACHBİLKENTAUBAYKUT007
- Keywords
- osteosarcopenia, sarcopenia, postmenopausal osteoporosis, kinesiophobia, fear of falling
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Ayşe Ukbe BaykutUniversity, hospital or other
- Collaborators
- Ankara Bilkent Sehir Hastanesi
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 17 Nov 2026 (estimated)
- First posted
- 2 Nov 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.
Osteosarcopenia (OSP) is defined as the coexistence of sarcopenia and osteoporosis/osteopenia. There is an intense and complex interaction-both mechanical (the "mechanostat" hypothesis) and biochemical (involving factors such as estrogen, testosterone, GH, IGF-1, IL-6, and osteocalcin)-between osteoporosis and sarcopenia. The general consensus is that sarcopenia leads to a reduction in bone mineral density. OSP is associated with significant physical disability, which poses a major threat to the future loss of independence. The increased propensity for falls-a consequence of sarcopenia-compounds the risk of fractures associated with osteoporosis, further exacerbating adverse health outcomes. Kinesiophobia, or the "fear of movement," is an excessive and irrational dread of performing physical movements or activities, stemming from the fear of a painful injury or the possibility of re-injury; this often leads to restrictions in activities of daily living. In a clinical setting, kinesiophobia is a critical issue that must be addressed to effectively manage a patient's disability, as it directly influences rehabilitation strategies. While there is some limited literature exploring the individual associations of osteoporosis and sarcopenia with kinesiophobia, no research has yet examined the relationship between osteosarcopenia and kinesiophobia. Our study aims to determine the impact of osteosarcopenia on kinesiophobia and quality of life in postmenopausal women.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| osteosarcopenia | – | Other: Dual-energy x-ray absorptiometer |
| osteoporosis | – | Other: Dual-energy x-ray absorptiometer |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with osteoporosis who present to a tertiary care center and meet the inclusion and exclusion criteria will be enrolled in sequential order.
Key inclusion criteria (4 listed)
- Possessing mental and physical competence
- Being a postmenopausal woman
- Being independently ambulatory
- Diagnosed with primary osteoporosis
Key exclusion criteria (11 listed)
- Infection
- Pacemaker
- Peripheral circulatory disorder
- Known concomitant malignancy or end-stage organ failure
- Known concomitant central and/or peripheral nervous system disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual-energy x-ray absorptiometerL1-L4 and L2-L4 regions, femoral neck T-scores, femoral neck BMD values, and body fat-muscle distribution will be evaluated. For appendicular skeletal muscle mass (ASM), the lean mass of the four extremities will be summed; an ASM value of <15 kg will be considered indicative of sarcopenia. ASM will be adjusted for body size (ASM/height² and ASM/BMI). | Other | osteoporosis, osteosarcopenia |
Primary outcome
Tampa Scale for Kinesiophobia
Time frame: baseline
The Tampa Scale for Kinesiophobia will be used to assess the fear of movement in patients. The scale consists of 17 items, with each item scored on a scale from 1 to 4. The minimum score that can be obtained is 17, and the maximum score is 68. In the studies, a score of 37 or higher has been defined as kinesiophobia.
International Falls Efficacy Scale
Time frame: baseline
The level of concern regarding falling will be assessed using the International Falls Efficacy Scale . The scale consists of 16 items, with each item scored on a scale from 1 to 4. The minimum possible score is 16 and the maximum is 64; a score of ≤19 indicates a low fear of falling, while a score of ≥28 indicates a high fear of falling.
Short Form-36 Health Survey (SF-36)
Time frame: baseline
The Short Form-36 Health Survey will be used to assess quality of life. It is a scale consisting of 8 subdimensions and a total of 36 items. The scoring ranges from 0 to 100, with higher scores indicating a better quality of life.
5 secondary outcomes
Grip strength
Time frame: baseline
Fracture Risk Assessment Tool
Time frame: baseline
calf circumference
Time frame: baseline
gait speed test
Time frame: baseline
Chair sit-to-stand test
Time frame: baseline
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly, due to participant privacy and ethical considerations.
Related trials for Osteosarcopenia
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Osteosarcopenia
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteosarcopenia and Sarcopenia, run by Ayşe Ukbe Baykut 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 4 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Scale for Kinesiophobia (time frame: baseline). The study lists 3 primary outcomes in all. 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 4 Nov 2026.