Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
Recruiting
Observational Study
HemodyalysisKidney TansplantOsteoporosisCKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
20 – 70
Sex
Any
Study type
Observational
Participants needed
180 (estimated)
Sponsor
Grigore T. Popa University of Medicine and Pharmacy · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 w…
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).
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