RecruitingNCT07141043
Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
New Directions and Perspectives in the Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
Sponsor
Grigore T. Popa University of Medicine and Pharmacy
Enrollment
180 participants
Start Date
Mar 19, 2025
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 20 YearsMax Age: 70 Years
Inclusion Criteria3
- HD group: Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent.
- 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.
- GPO group: men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent.
Exclusion Criteria3
- 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.
- KTR group: The same as for HD + return to dialysis + acute graft rejection.
- GPO group: The same as for HD + diabetes mellitus + prolonged glucocorticoid therapy (\>7.5 mg Prednisone or equivalent for at least 3 months).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07141043
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