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
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.