Vitamin D Status and Multi-Omics Profiles in Primary Osteoporosis (OP-MultiOmics)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Osteoporosis

Detailed Description

This observational study will enroll adults newly diagnosed with primary osteoporosis at Yichang Second People's Hospital.

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Li Chen, MD; Phone Number: +86-717-6741005; Email: chenli18995889811@163.com

Study Locations

• China
  • Hubei
    • Yichang, Hubei, China, 443000
      • Recruiting
      • Yichang Second People's Hospital
      • Contact: Li Chen, MD; Phone Number: +86-717-6741005; Email: chenli18995889811@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Mineral Density (BMD)	Bone mineral density measured at the lumbar spine and/or hip using dual-energy X-ray absorptiometry (DXA).	Baseline
Serum 25-Hydroxyvitamin D Level	Serum concentration of 25-hydroxyvitamin D (25(OH)D) assessed at enrollment to evaluate vitamin D status.	Baseline
Serum Calcium Level	Serum calcium concentration measured at enrollment as a routine biochemical indicator of bone metabolism.	Baseline
Serum Phosphate Level	Serum phosphate concentration measured at enrollment to assess mineral metabolism status.	Baseline
Serum Magnesium Level	Serum magnesium concentration measured at enrollment as part of biochemical evaluation related to bone health.	Baseline
Serum Osteocalcin Level	Serum osteocalcin concentration measured as a marker of bone formation.	Baseline
Serum Alkaline Phosphatase (ALP)	Serum alkaline phosphatase level assessed as an indicator of bone turnover and metabolic activity.	Baseline
Serum β-CTX Level	Serum C-terminal telopeptide of type I collagen (β-CTX) measured to evaluate bone resorption activity.	Baseline
Serum P1NP Level	Serum procollagen type 1 N-terminal propeptide (P1NP) measured as an additional bone formation marker.	Baseline

Collaborators and Investigators

• Sponsor: Dr. Li Chen

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Actual): December 22, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Vitamin D; Metabolomics; Biomarkers; Proteomics; Transcriptomics; Multi-omics; Primary Osteoporosis
• Other Study ID Numbers: YCSR202526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data including multi-omics datasets (transcriptomic, proteomic, metabolomic) and clinical measurements will be shared with qualified researchers upon reasonable request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No