Status:
RECRUITING
Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
Lead Sponsor:
Grigore T. Popa University of Medicine and Pharmacy
Conditions:
Hemodyalysis
Kidney Tansplant
Eligibility:
All Genders
20-70 years
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) ) common...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 19 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07141043
Start Date
March 19 2025
End Date
June 1 2027
Last Update
August 26 2025
Active Locations (1)
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1
University of Medicine and Pharmacy "Grigore T. Popa"
Iași, Romania