Bone health measurements for people with kidney transplants, on dialysis, or with age-related bone loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study comparing bone parameters in three groups: long-term hemodialysis patients, kidney transplant recipients at least one year post-transplant, and men or postmenopausal women with primary osteopenia/osteoporosis. Participants will undergo bone mineral density (BMD) testing, trabecular bone score (TBS) analysis, vertebral fracture assessment (VFA), and blood bone turnover markers (BTMs) with serum calcium and phosphate measured at baseline and after one year. Clinical care, including any CKD-MBD therapies for the KTR and HD groups, will continue as usual and will be recorded to examine associations with changes in bone measures. Analyses will compare baseline differences and 12-month changes to see how commonly used osteoporosis tools perform in CKD-MBD and transplant populations.

Why it matters

Who can join: the full rules

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).

Where it's running

• University of Medicine and Pharmacy "Grigore T. Popa"
  Iași, Romania Recruiting

Study contacts

• Study coordinator: Nada Akad, Dr.
• Email: akadnada@gmail.com
• Phone: 0040742015245

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.