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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Osteoporosis Patients | Adults newly diagnosed with primary osteoporosis (n=90) at Yichang Second People's Hospital. Blood and serum samples will be collected at the initial visit for transcriptomic, proteomic, and metabolomic analyses. No additional research sampling or follow-up will be performed. | ||
| Healthy Controls | Healthy adults without osteoporosis (n=30) at Yichang Second People's Hospital. Blood and serum samples will be collected at the initial visit for transcriptomic, proteomic, and metabolomic analyses. No additional research sampling or follow-up will be performed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Gene Expression Profiles Derived From Transcriptomic Analysis | Quantitative gene expression levels obtained from whole blood RNA sequencing, including the identification of differentially expressed genes and their expression magnitudes (e.g., log2 fold change, normalized counts). | Baseline |
| Serum Protein Abundance Profiles From Proteomic Analysis | Quantitative abundance of serum proteins measured through mass spectrometry-based proteomics, including identification of differentially expressed proteins and their relative abundance levels. | Baseline |
| Serum Metabolite Abundance Profiles From Metabolomics Analysis | Quantitative serum metabolite abundance determined by untargeted metabolomics, including identification of metabolites with altered abundance and their relative intensity values. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density (BMD) | Bone mineral density measured at the lumbar spine and/or hip using dual-energy X-ray absorptiometry (DXA). | Baseline |
| Serum 25-Hydroxyvitamin D Level | Serum concentration of 25-hydroxyvitamin D (25(OH)D) assessed at enrollment to evaluate vitamin D status. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from the outpatient and inpatient population of Yichang Second People's Hospital, including adults newly diagnosed with primary osteoporosis as well as healthy adult volunteers. Blood and serum samples will be collected at the hospital laboratory for multi-omics analyses.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Chen, MD | Contact | +86-717-6741005 | chenli18995889811@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yichang Second People's Hospital | Recruiting | Yichang | Hubei | 443000 | China |
De-identified individual participant data including multi-omics datasets (transcriptomic, proteomic, metabolomic) and clinical measurements will be shared with qualified researchers upon reasonable request.
De-identified individual participant data and supporting information will be available to qualified researchers starting after publication of the primary study results and will remain available for at least 5 years.
De-identified individual participant data and supporting information will be accessible to qualified researchers who submit a reasonable proposal and agree to a data use agreement. Data will be shared electronically after approval of the request.
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Whole blood, serum
| Baseline |
| Serum Calcium Level | Serum calcium concentration measured at enrollment as a routine biochemical indicator of bone metabolism. | Baseline |
| Serum Phosphate Level | Serum phosphate concentration measured at enrollment to assess mineral metabolism status. | Baseline |
| Serum Magnesium Level | Serum magnesium concentration measured at enrollment as part of biochemical evaluation related to bone health. | Baseline |
| Serum Osteocalcin Level | Serum osteocalcin concentration measured as a marker of bone formation. | Baseline |
| Serum Alkaline Phosphatase (ALP) | Serum alkaline phosphatase level assessed as an indicator of bone turnover and metabolic activity. | Baseline |
| Serum β-CTX Level | Serum C-terminal telopeptide of type I collagen (β-CTX) measured to evaluate bone resorption activity. | Baseline |
| Serum P1NP Level | Serum procollagen type 1 N-terminal propeptide (P1NP) measured as an additional bone formation marker. | Baseline |