OsteoporosisLUMINOSNCT07677072
Can Serum Lumican Level Identify a Hidden Fragility Phenotype Beyond Bone Mineral Density in Postmenopausal Women?
An observational study of Osteoporosis and Postmenopausal Osteoporosis, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Osteoporosis is a major cause of morbidity and fragility fractures in postmenopausal women. Bone mineral density (BMD) alone may not fully reflect fracture risk and skeletal fragility. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal Osteoporosis, Frailty
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 1 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of postmenopausal women aged 45 years and older who attend the Physical Medicine and Rehabilitation outpatient clinic and undergo routine osteoporosis evaluation, including bone mineral density measurement by DEXA and standard osteoporosis laboratory testing. Participants will be recruited consecutively and enrolled after providing written informed consent.
Who may be able to join
- Female sex
- Age 45 years or older
- Postmenopausal status
- Attendance at the Physical Medicine and Rehabilitation outpatient clinic
- Undergoing routine bone mineral density (DEXA) assessment and osteoporosis laboratory evaluation
- Ability and willingness to provide written informed consent
Who cannot join
- Premenopausal women
- Secondary causes of osteoporosis (e.g., malignancy, advanced renal failure, severe liver disease, significant endocrine disorders)
- Active infection or acute inflammatory disease
- Major surgery within the previous 6 months
- Neurological or muscular disorders that may significantly affect muscle function
- Inability to comply with study procedures and assessments
- Current treatment with medications that significantly affect bone metabolism, including bisphosphonates, denosumab, teriparatide, or other anti-osteoporotic agents
- 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
Osteoporosis is a major cause of morbidity and fragility fractures in postmenopausal women. Bone mineral density (BMD) alone may not fully reflect fracture risk and skeletal fragility. Lumican, an extracellular matrix proteoglycan involved in collagen organization and musculoskeletal tissue homeostasis, has emerged as a potential biomarker for bone health. This prospective observational study aims to investigate the relationship between serum lumican levels, bone mineral density, muscle strength, and clinical fragility indicators in postmenopausal women. Approximately 100 participants will undergo routine osteoporosis assessment including DEXA, laboratory testing, FRAX evaluation, and handgrip strength measurement. The study will evaluate whether serum lumican levels can identify a hidden fragility phenotype beyond conventional bone mineral density measurements.
Read the detailed description
This is a prospective, observational, single-center clinical study designed to evaluate serum lumican levels in postmenopausal women undergoing routine osteoporosis assessment. The study will investigate the association of lumican with bone mineral density, handgrip strength, FRAX-based fracture risk, history of falls, and fragility fracture history. No treatment or interventional procedure will be applied. Serum lumican will be measured from venous blood samples, and all other clinical and laboratory data will be collected as part of standard osteoporosis evaluation. The study aims to explore whether lumican may contribute to the identification of fragility risk beyond conventional bone mineral density measurements.
- Keywords
- Lumican, Osteoporosis, Fragility, FRAX
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal, Frailty
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 |
|---|---|---|
| Postmenopausal Women Undergoing Osteoporosis Evaluation | Postmenopausal women undergoing routine osteoporosis assessment will be included in this observational cohort. Participants will undergo bone mineral density measurement, routine osteoporosis laboratory evaluation, FRAX assessment, handgrip strength measurement, and serum lumican analysis. No treatment or interventional procedure will be administered as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Lumican Level and Bone Mineral Density Association
Assessment of the relationship between serum lumican levels and bone mineral density (lumbar spine, total hip, and femoral neck BMD measured by DEXA).
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 start15 May 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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
- Prospective
- Enrolment
- 98 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
- Investigators
- Dilek Ün oguzhanasiltürk, MD, Principal investigator, Kanuni Sultan and Süleyman Training Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677072
- Sponsor's protocol ID
- KSS-TRH-LUMICAN-OSTEO-2026
- Other IDs
- KSS-TRH-LUMICAN-OSTEO-2026
- Acronym
- LUMINOS
- Status last verified
- Jun 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: Individual participant data will not be shared because no formal data-sharing plan has been established. Participant confidentiality and privacy will be protected in accordance with institutional and ethical 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
- Can Serum Lumican Level Identify a Hidden Fragility Phenotype Beyond Bone Mineral Density in Postmenopausal Women?
- ClinicalTrials.gov ID
- NCT07677072
- Acronym / sponsor ID
- LUMINOS / KSS-TRH-LUMICAN-OSTEO-2026
- Keywords
- Lumican, Osteoporosis, Fragility, FRAX
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (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.
Osteoporosis is a major cause of morbidity and fragility fractures in postmenopausal women. Bone mineral density (BMD) alone may not fully reflect fracture risk and skeletal fragility. Lumican, an extracellular matrix proteoglycan involved in collagen organization and musculoskeletal tissue homeostasis, has emerged as a potential biomarker for bone health. This prospective observational study aims to investigate the relationship between serum lumican levels, bone mineral density, muscle strength, and clinical fragility indicators in postmenopausal women. Approximately 100 participants will undergo routine osteoporosis assessment including DEXA, laboratory testing, FRAX evaluation, and handgrip strength measurement. The study will evaluate whether serum lumican levels can identify a hidden fragility phenotype beyond conventional bone mineral density measurements.
Detailed description
This is a prospective, observational, single-center clinical study designed to evaluate serum lumican levels in postmenopausal women undergoing routine osteoporosis assessment. The study will investigate the association of lumican with bone mineral density, handgrip strength, FRAX-based fracture risk, history of falls, and fragility fracture history. No treatment or interventional procedure will be applied. Serum lumican will be measured from venous blood samples, and all other clinical and laboratory data will be collected as part of standard osteoporosis evaluation. The study aims to explore whether lumican may contribute to the identification of fragility risk beyond conventional bone mineral density measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal Women Undergoing Osteoporosis Evaluation | – | –Postmenopausal women undergoing routine osteoporosis assessment will be included in this observational cohort. Participants will undergo bone mineral density measurement, routine osteoporosis laboratory evaluation, FRAX assessment, handgrip strength measurement, and serum lumican analysis. No treatment or interventional procedure will be administered as part of the study. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of postmenopausal women aged 45 years and older who attend the Physical Medicine and Rehabilitation outpatient clinic and undergo routine osteoporosis evaluation, including bone mineral density measurement by DEXA and standard osteoporosis laboratory testing. Participants will be recruited consecutively and enrolled after providing written informed consent.
Key inclusion criteria (6 listed)
- Female sex
- Age 45 years or older
- Postmenopausal status
- Attendance at the Physical Medicine and Rehabilitation outpatient clinic
- Undergoing routine bone mineral density (DEXA) assessment and osteoporosis laboratory evaluation
Key exclusion criteria (8 listed)
- Premenopausal women
- Secondary causes of osteoporosis (e.g., malignancy, advanced renal failure, severe liver disease, significant endocrine disorders)
- Active infection or acute inflammatory disease
- Major surgery within the previous 6 months
- Neurological or muscular disorders that may significantly affect muscle function
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
Serum Lumican Level and Bone Mineral Density Association
Time frame: Baseline (at study enrollment)
Assessment of the relationship between serum lumican levels and bone mineral density (lumbar spine, total hip, and femoral neck BMD measured by DEXA).
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. Individual participant data will not be shared because no formal data-sharing plan has been established. Participant confidentiality and privacy will be protected in accordance with institutional and ethical 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.
Dilek Ün oguzhanasiltürk, MD principal investigator
Kanuni Sultan and Süleyman Training Resarch Hospital
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 Postmenopausal Osteoporosis, 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 8 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?
Serum Lumican Level and Bone Mineral Density Association (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.