CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder, Hemodyalysis, Kidney Tansplant, Osteoporosis
Conditions
Keywords
CKD-MBD, Osteoporosis, bone turnover markers
Brief summary
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.
Detailed description
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).
Interventions
None listed
Sponsors
Grigore T. Popa University of Medicine and Pharmacy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. HD group: Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent. 2. KTR 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. 3. GPO group: men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent.
Exclusion criteria
1. HD group: Treatment with active bone therapies (excluding calcium and vitamin D); ongoing cancer treatment or recent history of malignancy, cirrhosis, recent major fractures, patients who have received transplants other than kidney, secondary causes of osteoporosis (other than CKD or transplant-related: primary hyperparathyroidism, hyperthyroidism, congenital bone disorders, sarcoidosis, severe bone trauma, malignant tumors, inflammatory bowel disease, endogenous Cushing syndrome, anti-estrogen/anti-androgen therapy, and anorexia nervosa), pregnancy and breast-feeding. 2. KTR group: The same as for HD + return to dialysis + acute graft rejection. 3. GPO group: The same as for HD + diabetes mellitus + prolonged glucocorticoid therapy (\>7.5 mg Prednisone or equivalent for at least 3 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in BTM Levels in KTx recipients (KTR) compared to HD patients and general population osteopenia/osteoporosis (GPO) patients. | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between BTM Levels and BMD in KTR compared with HD and GPO patients. | 12 months | 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. |
| Correlation Between BTM Levels and TBS in KTR compared with HD and GPO patients. | 12 months | 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. |
| Key BTMs Predicting Bone Health Outcomes in KTR Patients | 12 months | Correlation between change from baseline in BTM and change from baseline in TBS. |
Countries
Romania
Contacts
Primary ContactNada Akad, Dr.
Outcome results
None listed