Recruiting NCT07677072

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

— Observational Osteoporosis Postmenopausal Osteoporosis Frailty Fragility Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Osteoporosis, Postmenopausal Osteoporosis, Frailty, Fragility Fractures. Basic parameters: from 45 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Turkey (Türkiye)
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

Serum Lumican Level and Bone Mineral Density Association [Time frame: Baseline (at study enrollment)]

Eligibility 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Turkey (Türkiye) · 1 center

Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey — Küçükçekmece

Identifiers

NCT: NCT07677072 · KSS-TRH-LUMICAN-OSTEO-2026 · KSS-TRH-LUMICAN-OSTEO-2026

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗