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

Kanuni Sultan Suleyman Training and Research Hospital

Status: Enrolling

Conditions: Postmenopausal Osteoporosis; Osteoporosis; Fragility Fractures; Frailty

Study type: Observational

Funder types: Other

Identifiers

NCT07677072

KSS-TRH-LUMICAN-OSTEO-2026 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

98 participants in 1 patient group

Postmenopausal Women Undergoing Osteoporosis Evaluation

Description:

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.