An observational study in Osteosarcopenia, Sarcopenia and Postmenopausal Osteoporosis, sponsored by Ayşe Ukbe Baykut. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Ayşe Ukbe Baykut · Observational
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's enrollment of 109 is close to the median of 120 across 455 observational studies indexed under Sarcopenia.
Browse Sarcopenia studies →Ayşe Ukbe Baykut is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with osteoporosis who present to a tertiary care center and meet the inclusion and exclusion criteria will be enrolled in sequential order.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Dual-energy x-ray absorptiometer
Other: Dual-energy x-ray absorptiometer
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
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.
Time frame: 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.
Time frame: baseline
calf circumference
For the calf circumference measurement, the measurement should be taken at the widest part of the calf while standing.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Plan to share: No — Individual participant data will not be shared publicly, due to participant privacy and ethical considerations.
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Nov 2026, 22 months after the start.
Of 192 non-industry observational studies under Sarcopenia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 63. This study's planned 22 months is below that.
Counting every sponsor, half of 194 studies reached it within 26 months; a quarter within 12 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Ayşe Ukbe Baykut