Health TrialsbyHealthPanel

Vitamin D Status and Multi-Omics Profiles in Primary Osteoporosis

ConditionPrimary Osteoporosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Li Chen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Primary Osteoporosis Patients
Group B: Healthy Controls

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline

Secondary outcomes

1

Bone Mineral Density (BMD)

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

Time frame
Baseline
2

Serum 25-Hydroxyvitamin D Level

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

Time frame
Baseline
3

Serum Calcium Level

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

Time frame
Baseline
4

Serum Phosphate Level

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Li Chen

Lead sponsor

Yichang Second People's Hospital

Sponsor institution

Source ClinicalTrials.gov
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