Vitamin D Status and Multi-Omics Profiles in Primary Osteoporosis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Primary Osteoporosis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
An Observational Study to Explore the Associations Between Vitamin D Status and Genomic, Proteomic, and Metabolomic Profiles in Patients With Primary Osteoporosis
Обзор
This observational study aims to explore the relationships between vitamin D status and genomic, proteomic, and metabolomic profiles in patients with primary osteoporosis. Eligible participants are adults who are newly diagnosed with primary osteoporosis at Yichang Second People's Hospital. Blood samples will be collected at the initial diagnosis to analyze gene expression, protein levels, and metabolic profiles. Participants will receive standard clinical treatment according to routine care, but no additional research sampling or follow-up will be performed. The study seeks to identify molecular patterns associated with osteoporosis and improve understanding of patient responses to therapy.
Подробное описание
This observational study will enroll adults newly diagnosed with primary osteoporosis at Yichang Second People's Hospital.
Blood samples will be collected at the initial diagnosis for multi-omics analysis, including transcriptomics, proteomics, and metabolomics. Clinical data, including bone mineral density, serum calcium, and vitamin D levels, will also be collected.
No additional research sampling or follow-up is planned after the initial visit.
Data analysis will focus on identifying molecular patterns associated with osteoporosis and potential biomarkers related to vitamin D status. All procedures will follow ethical guidelines and standard clinical practice.
Первичные конечные точки
- Gene Expression Profiles Derived From Transcriptomic Analysis [Срок оценки: Baseline]
- Serum Protein Abundance Profiles From Proteomic Analysis [Срок оценки: Baseline]
- Serum Metabolite Abundance Profiles From Metabolomics Analysis [Срок оценки: Baseline]
Вторичные конечные точки (9)
- Bone Mineral Density (BMD) [Срок оценки: Baseline]
- Serum 25-Hydroxyvitamin D Level [Срок оценки: Baseline]
- Serum Calcium Level [Срок оценки: Baseline]
- Serum Phosphate Level [Срок оценки: Baseline]
- Serum Magnesium Level [Срок оценки: Baseline]
- Serum Osteocalcin Level [Срок оценки: Baseline]
- Serum Alkaline Phosphatase (ALP) [Срок оценки: Baseline]
- Serum β-CTX Level [Срок оценки: Baseline]
- Serum P1NP Level [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Healthy controls: Adults aged ≥18 years, with normal bone mineral density (BMD) confirmed by dual-energy X-ray absorptiometry (DXA), without a history of bone metabolic diseases, major organ dysfunction, or chronic inflammatory/autoimmune diseases.
- Osteoporotic patients: Adults aged ≥18 years, newly diagnosed with primary osteoporosis according to clinical criteria (T-score ≤ -2.5 SD by DXA), without serious complications that may affect study results.
- Participants willing and able to provide written informed consent and cooperate with study procedures, including blood and serum sample collection and clinical data recording.
Критерии исключения
- Patients with secondary osteoporosis, including but not limited to osteoporosis caused by hyperparathyroidism, tumors, chronic kidney disease, liver cirrhosis, rheumatoid arthritis, or other autoimmune diseases.
- Individuals who have taken vitamin D supplements, anti-osteoporotic drugs, glucocorticoids, or other medications affecting vitamin D or bone metabolism within 3 months prior to enrollment.
- Pregnant or lactating women, or individuals with mental disorders preventing cooperation with study procedures.
- Individuals with acute infections, malignant tumors, or severe liver, kidney, cardiovascular, or cerebrovascular diseases that may affect study outcomes.
- Participants with a history of blood transfusion within 1 month prior to enrollment or those unable to provide peripheral blood samples as required.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Китай · 1 центр
- Yichang Second People's Hospital — Yichang
Идентификаторы
NCT: NCT07296471 · YCSR202526