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
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 design
Treatments tested in this trial
- Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsSponsors and collaborators
Dr. Li Chen
Lead sponsor
Yichang Second People's Hospital
Sponsor institution
Source ClinicalTrials.gov