Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
Recruiting now
Conditions studied: Hemodyalysis, Kidney Tansplant, Osteoporosis, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
In brief
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.
Key facts
- Study ID
- NCT07141043
- Run by
- Grigore T. Popa University of Medicine and Pharmacy
- People needed
- 180
- Starts
- 2025-03-19
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-08-26
Who can join
Age: 20 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- University of Medicine and Pharmacy "Grigore T. Popa" — Iași, Romania (enrolling)
Full record on ClinicalTrials.gov
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