NCT07296471Recruiting
Vitamin D Status and Multi-Omics 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
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 11 Nov 2025
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Dr. Li Chen
- Diseases
- Osteoporosis
- NCT number
- NCT07296471
What you commit to
- Study type: Observational
- Planned participants: 120
- From 11 Nov 2025 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Participants with a history of blood transfusion within 1 month prior to enrollment or those unable to provide peripheral blood samples as required.
Other illness
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yichang Second People's Hospital Coordinator of this site? Confirm its status | Yichang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.