Can Serum Lumican Level Identify a Hidden Fragility Phenotype Beyond Bone Mineral Density in Postmenopausal Women? (LUMINOS)

June 24, 2026 updated by: Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Küçükçekmece, Istanbul, Turkey (Türkiye), 34303
        • Recruiting
        • Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

Inclusion Criteria:

  • 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

Exclusion Criteria:

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (at study enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Dilek Ün oguzhanasiltürk, MD, Kanuni Sultan and Süleyman Training Resarch Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSS-TRH-LUMICAN-OSTEO-2026 (Other Identifier: Kanuni Sultan Süleyman Training and Research Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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