Can Serum Lumican Level Identify a Hidden Fragility Phenotype Beyond Bone Mineral Density in Postmenopausal Women?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Serum Lumican Level and Bone Mineral Density Association
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Serum Lumican Level and Bone Mineral Density Association
时间窗: 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).
次要结局
未报告次要终点
研究者
Dilek ün oguzhanasilturk
Physical Medicine and Rehabilitation Specialist
Kanuni Sultan Suleyman Training and Research Hospital