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

NCT07677072 | Recruiting

• 1 other identifier: KSS-TRH-LUMICAN-OSTEO-2026
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoporosis; Postmenopausal Osteoporosis; Frailty; Fragility Fractures

Keywords

Lumican; Osteoporosis; Fragility; FRAX

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (at study enrollment)

Study Arms (1)

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.

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Only postmenopausal women are eligible for participation because osteoporosis and fragility risk are being evaluated in a postmenopausal female population. Men and premenopausal women are excluded to ensure a homogeneous study population and to minimize the effects of sex- and hormone-related differences in bone metabolism.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey

Küçükçekmece, Istanbul, 34303, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal; Frailty

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Ün oguzhanasiltürk, MD

  Kanuni Sultan and Süleyman Training Resarch Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Ün Oğuzhanasiltürk, MD

CONTACT

+90 5056367184; dilekunoguzhan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)