Bone health measurements for people with kidney transplants, on dialysis, or with age-related bone loss
New Directions and Perspectives in the Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
This project will try using standard osteoporosis tests (BMD, TBS, VFA, and blood bone turnover markers) to check bone disease in adults on hemodialysis or after kidney transplant compared with people who have primary osteopenia/osteoporosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Grigore T. Popa University of Medicine and Pharmacy Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Iași) |
| Trial ID | NCT07141043 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20–70 who have been on hemodialysis for at least 12 months or had a kidney transplant at least 12 months prior, and men or postmenopausal women aged 50–70 with primary osteopenia/osteoporosis.
Not a fit: People on active bone therapies (other than calcium or vitamin D), those with ongoing cancer treatment, recent major fractures, cirrhosis, non-kidney organ transplants, secondary causes of osteoporosis other than CKD or transplant-related causes, or those outside the specified age ranges are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this could help clinicians use common osteoporosis tests to better identify bone disease and fracture risk in people on dialysis or after kidney transplant.
How similar studies have performed: Previous work applying BMD and BTMs to CKD and transplant patients has produced mixed results, and prospective head-to-head comparisons with general-population osteoporosis patients remain limited.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Iași
- University of Medicine and Pharmacy "Grigore T. Popa" — Iași, Romania (Recruiting)
Study contacts
- Study coordinator: Nada Akad, Dr.
- Email: akadnada@gmail.com
- Phone: 0040742015245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.