None listed
Conditions
Interventions
None listed
Sponsors
Korea University Ansan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: #. Retrospective Cohort Inclusion Criteria - Adults who underwent bone mineral density (BMD) testing at our institution during the past ~20 years with longitudinal DXA follow-up at intervals =1 year. - Lumbar spine radiographs (AP and lateral) obtained within ±3 months of each DXA time point. #. Prospective Cohort Inclusion Criteria - Patients visiting our institution who meet any of the following: - Women =65 years or men =70 years with osteoporosis or osteopenia meeting FRAX treatment thresholds, confirmed as requiring treatment; - Patients younger than the above age thresholds may be included if investigator assessment and testing confirm a need for treatment. - Patients already on osteoporosis medication may be included if continued therapy for =6 months is planned and the study team deems inclusion aligned with study objectives. - Able to complete =6 months of follow-up from study start. - DXA, blood tests, and lumbar spine radiographs can be obtained both at baseline and at the 6-month follow-up. - The 6-month follow-up window is anchored to the treatment initiation date. - Ability to collect baseline clinical information (sex, age, height, weight, etc.) at enrollment.
Exclusion criteria
Exclusion criteria: #. Retrospective Cohort Exclusion Criteria - Imaging data not available (missing or not archived). - Imaging available but not suitable for analysis, including: - Poor image quality. - History of lumbar spinal fusion/fixation or implants (e.g., instrumentation, cement augmentation) that may confound interpretation. - Pathologic fracture, congenital or severe spinal deformity, or infection that precludes analysis. #. Prospective Cohort Exclusion Criteria - Failure to complete the required assessments at baseline and at the 6-month follow-up. - Note: Follow-up assessments are acceptable if performed from Day 151 (5 months + 1 day) to Day 180 (6 months) after the first study test. - Imaging obtained but unsuitable for analysis, including: - Poor image quality. - History of lumbar spinal fusion/fixation or implants (e.g., instrumentation, cement augmentation) that may confound interpretation. - Pathologic fracture, congenital or severe spinal deformity, or infection that precludes analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in bone turnover marker (CTX, P1NP) at 6 months from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation/regression between imaging-based indices and ?CTX/?P1NP;Responder rate (e.g., =25% decrease in CTX or =20% change in P1NP) with AUC/accuracy/sensitivity/specificity | — |
Countries
Korea, Republic of
Contacts
Public ContactHyung Jun Park
Korea University Ansan Hospital
Outcome results
None listed