Vitamin D and blood molecular profiles in primary osteoporosis
Official title: An Observational Study to Explore the Associations Between Vitamin D Status and Genomic, Proteomic, and Metabolomic Profiles in Patients With Primary Osteoporosis
Run by Yichang Second People's Hospital · NCT07296471 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Yichang Second People's Hospital Academic / other |
| Locations | 1 site (Yichang, Hubei) |
| Status | Recruiting |
| Started | November 11, 2025 |
| Main results expected | November 30, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT07296471 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous multi-omics and vitamin D studies in bone disease have reported some promising associations, but the evidence is early and requires further validation.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Yichang Second People's Hospital
Yichang, Hubei, China Recruiting
Study contacts
- Study coordinator: Li Chen, MD
- Email: chenli18995889811@163.com
- Phone: +86-717-6741005
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.