Vitamin D Status and Multi-Omics Profiles in Primary Osteoporosis
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: Primary Osteoporosis. Basic parameters: from 18 years · All.
- 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
- China
- 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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Official title
An Observational Study to Explore the Associations Between Vitamin D Status and Genomic, Proteomic, and Metabolomic Profiles in Patients With Primary Osteoporosis
Overview
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.
Primary outcome measures
- Gene Expression Profiles Derived From Transcriptomic Analysis [Time frame: Baseline]
- Serum Protein Abundance Profiles From Proteomic Analysis [Time frame: Baseline]
- Serum Metabolite Abundance Profiles From Metabolomics Analysis [Time frame: Baseline]
Secondary outcome measures (9)
- Bone Mineral Density (BMD) [Time frame: Baseline]
- Serum 25-Hydroxyvitamin D Level [Time frame: Baseline]
- Serum Calcium Level [Time frame: Baseline]
- Serum Phosphate Level [Time frame: Baseline]
- Serum Magnesium Level [Time frame: Baseline]
- Serum Osteocalcin Level [Time frame: Baseline]
- Serum Alkaline Phosphatase (ALP) [Time frame: Baseline]
- Serum β-CTX Level [Time frame: Baseline]
- Serum P1NP Level [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Yichang Second People's Hospital — Yichang
Identifiers
NCT: NCT07296471 · YCSR202526