Yichang Second People's Hospital
Yichang, Hubei, 443000, China
Location status: Recruiting
NCT Number: NCT07296471
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Yichang, Hubei, 443000, China
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: Baseline
Quantitative serum metabolite abundance determined by untargeted metabolomics, including identification of metabolites with altered abundance and their relative intensity values.
Time frame: Baseline
Bone mineral density measured at the lumbar spine and/or hip using dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline
Serum concentration of 25-hydroxyvitamin D (25(OH)D) assessed at enrollment to evaluate vitamin D status.
Time frame: Baseline
Serum calcium concentration measured at enrollment as a routine biochemical indicator of bone metabolism.
Time frame: Baseline
Serum phosphate concentration measured at enrollment to assess mineral metabolism status.
Time frame: Baseline
Serum magnesium concentration measured at enrollment as part of biochemical evaluation related to bone health.
Time frame: Baseline
Serum osteocalcin concentration measured as a marker of bone formation.
Time frame: Baseline
Serum alkaline phosphatase level assessed as an indicator of bone turnover and metabolic activity.
Time frame: Baseline
Serum C-terminal telopeptide of type I collagen (β-CTX) measured to evaluate bone resorption activity.
Time frame: Baseline
Serum procollagen type 1 N-terminal propeptide (P1NP) measured as an additional bone formation marker.
Contact information is provided by the study sponsor or research team.
Dr. Li Chen
Other
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
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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