Primary Osteoporosis
Conditions
Keywords
Primary Osteoporosis, Vitamin D, Multi-omics, Transcriptomics, Proteomics, Metabolomics, Biomarkers
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Dr. Li Chen
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. 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. 3. Participants willing and able to provide written informed consent and cooperate with study procedures, including blood and serum sample collection and clinical data recording.
Exclusion criteria
1. 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. 2. 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. 3. Pregnant or lactating women, or individuals with mental disorders preventing cooperation with study procedures. 4. Individuals with acute infections, malignant tumors, or severe liver, kidney, cardiovascular, or cerebrovascular diseases that may affect study outcomes. 5. Participants with a history of blood transfusion within 1 month prior to enrollment or those unable to provide peripheral blood samples as required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gene Expression Profiles Derived From Transcriptomic Analysis | Baseline | 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). |
| Serum Protein Abundance Profiles From Proteomic Analysis | Baseline | Quantitative abundance of serum proteins measured through mass spectrometry-based proteomics, including identification of differentially expressed proteins and their relative abundance levels. |
| Serum Metabolite Abundance Profiles From Metabolomics Analysis | Baseline | Quantitative serum metabolite abundance determined by untargeted metabolomics, including identification of metabolites with altered abundance and their relative intensity values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Calcium Level | Baseline | Serum calcium concentration measured at enrollment as a routine biochemical indicator of bone metabolism. |
| Serum Phosphate Level | Baseline | Serum phosphate concentration measured at enrollment to assess mineral metabolism status. |
| Serum Magnesium Level | Baseline | Serum magnesium concentration measured at enrollment as part of biochemical evaluation related to bone health. |
| Serum P1NP Level | Baseline | Serum procollagen type 1 N-terminal propeptide (P1NP) measured as an additional bone formation marker. |
| Serum Alkaline Phosphatase (ALP) | Baseline | Serum alkaline phosphatase level assessed as an indicator of bone turnover and metabolic activity. |
| Serum β-CTX Level | Baseline | Serum C-terminal telopeptide of type I collagen (β-CTX) measured to evaluate bone resorption activity. |
| Serum Osteocalcin Level | Baseline | Serum osteocalcin concentration measured as a marker of bone formation. |
| Bone Mineral Density (BMD) | Baseline | Bone mineral density measured at the lumbar spine and/or hip using dual-energy X-ray absorptiometry (DXA). |
| Serum 25-Hydroxyvitamin D Level | Baseline | Serum concentration of 25-hydroxyvitamin D (25(OH)D) assessed at enrollment to evaluate vitamin D status. |
Countries
China
Contacts
Primary ContactLi Chen, MD
Outcome results
None listed