Primary OsteoporosisOP-MultiOmicsNCT07296471
Vitamin D Status and Multi-Omics Profiles in Primary Osteoporosis
An observational study of Primary Osteoporosis, run by Dr. Li Chen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Osteoporosis
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yichang Second People's Hospital
Yichang, Hubei, 443000
Li Chen, MD, +86-717-6741005, chenli18995889811@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Osteoporosis
- Keywords
- Primary Osteoporosis, Vitamin D, Multi-omics, Transcriptomics, Proteomics, Metabolomics, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (9)
Bone Mineral Density (BMD)
Bone mineral density measured at the lumbar spine and/or hip using dual-energy X-ray absorptiometry (DXA).
Measured: Baseline
Serum 25-Hydroxyvitamin D Level
Serum concentration of 25-hydroxyvitamin D (25(OH)D) assessed at enrollment to evaluate vitamin D status.
Measured: Baseline
Serum Calcium Level
Serum calcium concentration measured at enrollment as a routine biochemical indicator of bone metabolism.
Measured: Baseline
Serum Phosphate Level
Serum phosphate concentration measured at enrollment to assess mineral metabolism status.
Measured: Baseline
Serum Magnesium Level
Serum magnesium concentration measured at enrollment as part of biochemical evaluation related to bone health.
Measured: Baseline
Serum Osteocalcin Level
Serum osteocalcin concentration measured as a marker of bone formation.
Measured: Baseline
Serum Alkaline Phosphatase (ALP)
Serum alkaline phosphatase level assessed as an indicator of bone turnover and metabolic activity.
Measured: Baseline
Serum β-CTX Level
Serum C-terminal telopeptide of type I collagen (β-CTX) measured to evaluate bone resorption activity.
Measured: Baseline
Serum P1NP Level
Serum procollagen type 1 N-terminal propeptide (P1NP) measured as an additional bone formation marker.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start11 Nov 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Li Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Li Chen, Yichang Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296471
- Sponsor's protocol ID
- YCSR202526
- Acronym
- OP-MultiOmics
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data including multi-omics datasets (transcriptomic, proteomic, metabolomic) and clinical measurements will be shared with qualified researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Explore the Associations Between Vitamin D Status and Genomic, Proteomic, and Metabolomic Profiles in Patients With Primary Osteoporosis
- ClinicalTrials.gov ID
- NCT07296471
- Acronym / sponsor ID
- OP-MultiOmics / YCSR202526
- Conditions
- Primary Osteoporosis
- Keywords
- Primary Osteoporosis, Vitamin D, Multi-omics, Transcriptomics, Proteomics, Metabolomics, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr. Li ChenUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
9 secondary outcomes
Bone Mineral Density (BMD)
Time frame: Baseline
Serum 25-Hydroxyvitamin D Level
Time frame: Baseline
Serum Calcium Level
Time frame: Baseline
Serum Phosphate Level
Time frame: Baseline
Serum Magnesium Level
Time frame: Baseline
Serum Osteocalcin Level
Time frame: Baseline
Serum Alkaline Phosphatase (ALP)
Time frame: Baseline
Serum β-CTX Level
Time frame: Baseline
Serum P1NP Level
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data including multi-omics datasets (transcriptomic, proteomic, metabolomic) and clinical measurements will be shared with qualified researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Osteoporosis, run by Dr. Li Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Chen, MD (+86-717-6741005, chenli18995889811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene Expression Profiles Derived From Transcriptomic Analysis (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.