Vitamin D Status and Multi-Omics Profiles in Primary Osteoporosis

NCT07296471 | Recruiting

• 1 other identifier: YCSR202526
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Osteoporosis

Keywords

Primary Osteoporosis; Vitamin D; Multi-omics; Transcriptomics; Proteomics; Metabolomics; Biomarkers

Outcome Measures

Primary Outcomes (3)

• Gene Expression Profiles Derived From Transcriptomic Analysis

  Quantitative gene expression levels obtained from whole blood RNA sequencing, including the identification of differentially expressed genes and their expression magnitudes (e.g., log2 fold change, normalized counts).

  Baseline

• Serum Protein Abundance Profiles From Proteomic Analysis

  Quantitative abundance of serum proteins measured through mass spectrometry-based proteomics, including identification of differentially expressed proteins and their relative abundance levels.

  Baseline

• Serum Metabolite Abundance Profiles From Metabolomics Analysis

  Quantitative serum metabolite abundance determined by untargeted metabolomics, including identification of metabolites with altered abundance and their relative intensity values.

  Baseline

Secondary Outcomes (9)

• Bone Mineral Density (BMD)

  Baseline

• Serum 25-Hydroxyvitamin D Level

  Baseline

• Serum Calcium Level

  Baseline

• Serum Phosphate Level

  Baseline

• Serum Magnesium Level

  Baseline

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the outpatient and inpatient population of Yichang Second People's Hospital, including adults newly diagnosed with primary osteoporosis as well as healthy adult volunteers. Blood and serum samples will be collected at the hospital laboratory for multi-omics analyses.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Li Chen: lead

Study Sites (1)

Yichang Second People's Hospital

Yichang, Hubei, 443000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

Central Study Contacts

Li Chen, MD

CONTACT

+86-717-6741005; chenli18995889811@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician, Department of Laboratory Medicine, Yichang Second People's Hospital

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 22, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: De-identified individual participant data and supporting information will be available to qualified researchers starting after publication of the primary study results and will remain available for at least 5 years.
• Access Criteria: De-identified individual participant data and supporting information will be accessible to qualified researchers who submit a reasonable proposal and agree to a data use agreement. Data will be shared electronically after approval of the request.

Locations

CN (1)