Vitamin D and blood molecular profiles in primary osteoporosis

An Observational Study to Explore the Associations Between Vitamin D Status and Genomic, Proteomic, and Metabolomic Profiles in Patients With Primary Osteoporosis

This project will see if vitamin D levels are linked to blood gene, protein, and metabolite patterns in adults newly diagnosed with primary osteoporosis.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yichang Second People's Hospital (other)
• Locations: 1 site (Yichang, Hubei)
• Trial ID: NCT07296471 on ClinicalTrials.gov

What this trial studies

This observational project enrolls adults newly diagnosed with primary osteoporosis at Yichang Second People's Hospital and collects a single blood sample at the time of diagnosis. Samples will undergo multi-omics analysis including transcriptomics, proteomics, and metabolomics, and clinical data such as bone mineral density, serum calcium, and vitamin D will be recorded. Participants will receive standard clinical care with no additional research follow-up or sampling after the initial visit. The analysis aims to identify molecular patterns and potential biomarkers related to vitamin D status and bone health.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) newly diagnosed with primary osteoporosis by DXA who have not used vitamin D supplements or osteoporosis medications and can give informed consent.

Not a fit: People with secondary osteoporosis, recent or current vitamin D or anti-osteoporotic treatment, or major comorbid conditions are unlikely to benefit from the study findings.

Why it matters

Potential benefit: If successful, the work could identify biomarkers that help explain how vitamin D relates to bone loss and guide more personalized treatment decisions.

How similar studies have performed: Previous multi-omics and vitamin D studies in bone disease have reported some promising associations, but the evidence is early and requires further validation.

Eligibility criteria

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.

Where this trial is running

Yichang, Hubei

• Yichang Second People's Hospital — Yichang, Hubei, China (RECRUITING)

Study contacts

• Study coordinator: Li Chen, MD

Conditions: Primary Osteoporosis, Vitamin D, Multi-omics, Transcriptomics, Proteomics, Metabolomics, Biomarkers