Actively Recruiting
New Directions and Perspectives in the Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
Led by Grigore T. Popa University of Medicine and Pharmacy · Updated on 2025-08-26
180
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating bone health measurements in patients with chronic kidney disease and kidney transplant recipients to improve assessment of mineral and bone disorders related to kidney disease. This observational study compares bone mineral density, bone turnover markers, vertebral fracture assessment, and trabecular bone score among hemodialysis patients, kidney transplant recipients, and general population patients with osteopenia or osteoporosis. The goal is to enhance understanding of bone changes in these groups over time. Participants include three groups: those undergoing hemodialysis for at least 12 months, kidney transplant recipients with a transplant performed at least 12 months prior, and men or postmenopausal women diagnosed with primary osteopenia or osteoporosis. Bone measurements and blood tests will be collected at the start and after one year, with or without treatment for mineral and bone disorders. The study does not intervene but observes and compares bone health parameters across groups. During the study, participants will undergo assessments including bone mineral density scans, bone turnover marker blood tests, vertebral fracture evaluations, and trabecular bone score measurements. Researchers will monitor changes in these parameters over 12 months to understand bone health differences and correlations in the study groups. Safety and treatment information will be recorded, and participants' involvement will last about one year.
CONDITIONS
Brief Title
Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing hemodialysis for at least 12 months, aged 20 to 70 years, who have signed informed consent
- Patients with successful kidney transplant performed at least 12 months prior, aged 20 to 70 years, who have signed informed consent
- Men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50 to 70 years, who have signed informed consent
You will not qualify if you...
- Treatment with active bone therapies other than calcium and vitamin D
- Ongoing cancer treatment or recent history of malignancy
- Cirrhosis or recent major fractures
- Patients who have received transplants other than kidney
- Secondary causes of osteoporosis not related to chronic kidney disease or transplant, such as 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 breastfeeding
- Return to dialysis or acute graft rejection for kidney transplant recipients
- Diabetes mellitus and prolonged glucocorticoid therapy (>7.5 mg Prednisone or equivalent for at least 3 months) for general population osteoporosis group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Baseline
Participants undergo assessments of bone mineral density, trabecular bone score, vertebral fracture assessment, and bone turnover markers, as well as serum calcium and phosphate measurements.
1 visit (in-person)
Duration - 12 months
Participants are monitored to evaluate changes in bone parameters over one year, with or without therapeutic intervention for chronic kidney disease-mineral and bone disorder.
Periodic visits over 12 months
Trial Site Locations
Total: 1 location
1
University of Medicine and Pharmacy "Grigore T. Popa"
Iași, Romania
Actively Recruiting
Research Team
N
Nada Akad, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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