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This study aims to integrate bone measurements (including bone turnover markers (BTM), bone mineral density (BMD) measurement, vertebral fracture assessment (VFA), trabecular bone score (TBS) ) commonly used in the general population for primary osteoporosis evaluation to enhance the assessment of CKD-MBD.
Prospective observational study that will evaluate differences in bone (BMD, TBS, VFA and BTMs, serum calcium and phosphate) parameters in hemodialysis (HD) patients and kidney transplant recipients (KTR), compared to general population osteopenia/osteoporosis patients, at baseline and after one year of monitoring, with or without therapeutic intervention for CKD-MBD (KTR and HD groups).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialysis group | Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent. | ||
| Kidney transplant group | Patients with successful KTx performed at least 12 months prior to their enrollment, aged 20-70 years old, after signing an informed consent. Subjects will be eligible for inclusion regardless of KTx immunosuppression regimen, pre-transplantation history, history of pre-transplant dialysis, or whether the kidney donation was from a living or deceased donor. | ||
| General population osteoporosis/osteopenia | Men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in BTM Levels in KTx recipients (KTR) compared to HD patients and general population osteopenia/osteoporosis (GPO) patients. | Longitudinal assessment of BTMs, including serum procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b) in KTR compared with HD patients and GPO patients. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between BTM Levels and BMD in KTR compared with HD and GPO patients. | Correlation analysis between BTM levels (procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b)) and BMD (g/cm²) assessed by dual-energy X-ray absorptiometry (DXA) at the lumbar spine, femoral neck and forearm. Data will be stratified by study group (KTR, HD and GPO patients) and by gender. Correlation coefficients will be reported for each group. |
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Inclusion Criteria:
Exclusion Criteria:
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Men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old and patients undergoing HD or KTR, aged 20-70 years old.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nada Akad, Dr. | Contact | 0040742015245 | akadnada@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine and Pharmacy "Grigore T. Popa" | Recruiting | Iași | Romania |
Individual participant data will not be shared due to privacy concerns and data protection regulations.
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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Serum
| 12 months |
| Correlation Between BTM Levels and TBS in KTR compared with HD and GPO patients. | Correlation analysis between BTM levels (procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b)) and TBS (unitless index) derived from DXA images at the lumbar spine. Data will be stratified by study group (KTR, HD and GPO patients) and by gender. Correlation coefficients will be reported for each group. | 12 months |
| Key BTMs Predicting Bone Health Outcomes in KTR Patients | Correlation between change from baseline in BTM and change from baseline in TBS. | 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D012279 | Rickets |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |