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NCT Number: NCT07296471

Vitamin D Status and Multi-Omics Profiles in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Gene Expression Profiles Derived From Transcriptomic Analysis

    Time frame: Baseline

    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).

  2. Serum Protein Abundance Profiles From Proteomic Analysis

    Time frame: Baseline

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

  3. Serum Metabolite Abundance Profiles From Metabolomics Analysis

    Time frame: Baseline

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

Secondary outcomes

  1. Bone Mineral Density (BMD)

    Time frame: Baseline

    Bone mineral density measured at the lumbar spine and/or hip using dual-energy X-ray absorptiometry (DXA).

  2. Serum 25-Hydroxyvitamin D Level

    Time frame: Baseline

    Serum concentration of 25-hydroxyvitamin D (25(OH)D) assessed at enrollment to evaluate vitamin D status.

  3. Serum Calcium Level

    Time frame: Baseline

    Serum calcium concentration measured at enrollment as a routine biochemical indicator of bone metabolism.

  4. Serum Phosphate Level

    Time frame: Baseline

    Serum phosphate concentration measured at enrollment to assess mineral metabolism status.

  5. Serum Magnesium Level

    Time frame: Baseline

    Serum magnesium concentration measured at enrollment as part of biochemical evaluation related to bone health.

  6. Serum Osteocalcin Level

    Time frame: Baseline

    Serum osteocalcin concentration measured as a marker of bone formation.

  7. Serum Alkaline Phosphatase (ALP)

    Time frame: Baseline

    Serum alkaline phosphatase level assessed as an indicator of bone turnover and metabolic activity.

  8. Serum β-CTX Level

    Time frame: Baseline

    Serum C-terminal telopeptide of type I collagen (β-CTX) measured to evaluate bone resorption activity.

  9. Serum P1NP Level

    Time frame: Baseline

    Serum procollagen type 1 N-terminal propeptide (P1NP) measured as an additional bone formation marker.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Chen, MD

CONTACT

[email protected]

+86-717-6741005

Sponsors and collaborators

Lead sponsor

Dr. Li Chen

Other

Registry information

Official study title

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

Acronym: OP-MultiOmics

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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