OsteoporosisNCT07045012
The Relationship Between Osteoporosis and Sarcopenia Parameters in Postmenopausal Women Under 60
An observational study of Osteoporosis, run by Beylikduzu State Hospital.
Trial summary
This cross-sectional study will include postmenopausal women under the age of 60 who visited the Physical Medicine and Rehabilitation outpatient clinic at Beylikdüzü State Hospital between June 25 and July 25, 2025. Read more about this study
- Who is it for?
- Ages 50 to 59 years, women only
- Conditions the study is for
- Osteoporosis
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2025to 25 Jul 2025
- How long will I take part?
- 1 Day
- 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 50 to 59 years
- Women only
- Adult
Study population: Postmenopausal women under 60 years
Who may be able to join
- Women under 60 years of age who are postmenopausal.
- Patients with or without a diagnosis of osteoporosis:
- Osteoporosis group: T-score ≤ -2.5 in femoral neck or L1-L4 region. Control group: T-score ≥ -1.0 in femoral neck and L1-L4 region.
- -Patients who provide written informed consent to participate in the study.
Who cannot join
- Refusal to participate in the study.
- Presence of neuromuscular diseases that could cause muscle loss.
- History of infection, recent surgery, or trauma.
- Presence of psychiatric disorders.
- Cognitive impairment that could interfere with test performance or data reliability.
- Use of medications that could affect study outcomes (e.g., corticosteroids, muscle relaxants, or medications influencing bone/muscle metabolism).
About this study
Official title: The Relationship Between Osteoporosis and Sarcopenia Parameters in Postmenopausal Women Under 60: A Cross-Sectional Study
This cross-sectional study will include postmenopausal women under the age of 60 who visited the Physical Medicine and Rehabilitation outpatient clinic at Beylikdüzü State Hospital between June 25 and July 25, 2025. Participants must have undergone a bone mineral density (BMD) assessment within the past six months using Dual X-ray Absorptiometry (DXA). Both osteoporotic and non-osteoporotic patients will be enrolled. Sociodemographic data such as age, height, weight, and BMI will be recorded. Femoral neck and L1-L4 T-scores and BMD values will be obtained from existing DXA results. Information on osteoporosis treatment, presence of fecal incontinence, constipation, and medication use will be collected. In the second phase, sarcopenia will be assessed according to EWGSOP2 criteria using bioelectrical impedance analysis for skeletal muscle mass, handgrip strength, and the five-time sit-to-stand test. Differences between the osteoporotic and non-osteoporotic groups will be analyzed.
- Conditions
- Osteoporosis
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Mass
Measured by bioelectrical impedance analysis (BIA), this assesses the amount of muscle tissue in the body. Low skeletal muscle mass indicates sarcopenia.
Measured: 0 day
Handgrip Strength
This is a simple test to measure muscle strength. Reduced handgrip strength is a sign of sarcopenia.
Measured: 0 day
5 times chair stand test
The Five Times Sit-to-Stand Test is a simple and widely used functional assessment tool to evaluate lower extremity muscle strength, balance, and mobility.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start25 Jun 2025 (estimated)
- Primary completion25 Jul 2025 (estimated)
- Study completion25 Jul 2025 (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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045012
- Sponsor's protocol ID
- Beylikdüzüstateh20
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Osteoporosis and Sarcopenia Parameters in Postmenopausal Women Under 60: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07045012
- Acronym / sponsor ID
- Beylikdüzüstateh20
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 25 Jul 2025 (estimated)
- First posted
- 1 Jul 2025 (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.
This cross-sectional study will include postmenopausal women under the age of 60 who visited the Physical Medicine and Rehabilitation outpatient clinic at Beylikdüzü State Hospital between June 25 and July 25, 2025. Participants must have undergone a bone mineral density (BMD) assessment within the past six months using Dual X-ray Absorptiometry (DXA). Both osteoporotic and non-osteoporotic patients will be enrolled. Sociodemographic data such as age, height, weight, and BMI will be recorded. Femoral neck and L1-L4 T-scores and BMD values will be obtained from existing DXA results. Information on osteoporosis treatment, presence of fecal incontinence, constipation, and medication use will be collected. In the second phase, sarcopenia will be assessed according to EWGSOP2 criteria using bioelectrical impedance analysis for skeletal muscle mass, handgrip strength, and the five-time sit-to-stand test. Differences between the osteoporotic and non-osteoporotic groups will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 50 to 59 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Postmenopausal women under 60 years
Key inclusion criteria (4 listed)
- Women under 60 years of age who are postmenopausal.
- Patients with or without a diagnosis of osteoporosis:
- Osteoporosis group: T-score ≤ -2.5 in femoral neck or L1-L4 region. Control group: T-score ≥ -1.0 in femoral neck and L1-L4 region.
- -Patients who provide written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Refusal to participate in the study.
- Presence of neuromuscular diseases that could cause muscle loss.
- History of infection, recent surgery, or trauma.
- Presence of psychiatric disorders.
- Cognitive impairment that could interfere with test performance or data reliability.
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
Skeletal Muscle Mass
Time frame: 0 day
Measured by bioelectrical impedance analysis (BIA), this assesses the amount of muscle tissue in the body. Low skeletal muscle mass indicates sarcopenia.
Handgrip Strength
Time frame: 0 day
This is a simple test to measure muscle strength. Reduced handgrip strength is a sign of sarcopenia.
5 times chair stand test
Time frame: 0 day
The Five Times Sit-to-Stand Test is a simple and widely used functional assessment tool to evaluate lower extremity muscle strength, balance, and mobility.
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 1 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Beylikduzu State Hospital.
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 6 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: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Skeletal Muscle Mass (time frame: 0 day). 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 1 Jul 2025.