Vitamin D Status and Multi-Omics Profiles in Primary Osteoporosis
NCT ID: NCT07296471
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2025-11-11
2027-11-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Primary Osteoporosis Patients
Adults newly diagnosed with primary osteoporosis (n=90) at Yichang Second People's Hospital. Blood and serum samples will be collected at the initial visit for transcriptomic, proteomic, and metabolomic analyses. No additional research sampling or follow-up will be performed.
No interventions assigned to this group
Healthy Controls
Healthy adults without osteoporosis (n=30) at Yichang Second People's Hospital. Blood and serum samples will be collected at the initial visit for transcriptomic, proteomic, and metabolomic analyses. No additional research sampling or follow-up will be performed.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Dr. Li Chen
OTHER
Responsible Party
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Dr. Li Chen
Associate Chief Physician, Department of Laboratory Medicine, Yichang Second People's Hospital
Locations
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Yichang Second People's Hospital
Yichang, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Li Chen, MD
Role: primary
Other Identifiers
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YCSR202526
Identifier Type: -
Identifier Source: org_study_id