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NCT Number: NCT07141043

Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients

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.

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Key information

About this study

Prospective observational study that will evaluate differences in bone (BMD, TBS, VFA and BTMs, serum calcium and phosphate) parameters in hemodialysis (HD) patients and kidney transplant recipients (KTR), compared to general population osteopenia/osteoporosis patients, at baseline and after one year of monitoring, with or without therapeutic intervention for CKD-MBD (KTR and HD groups).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. Change in BTM Levels in KTx recipients (KTR) compared to HD patients and general population osteopenia/osteoporosis (GPO) patients.

    Time frame: 12 months

    Longitudinal assessment of BTMs, including serum procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b) in KTR compared with HD patients and GPO patients.

Secondary outcomes

  1. Correlation Between BTM Levels and BMD in KTR compared with HD and GPO patients.

    Time frame: 12 months

    Correlation analysis between BTM levels (procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b)) and BMD (g/cm²) assessed by dual-energy X-ray absorptiometry (DXA) at the lumbar spine, femoral neck and forearm. Data will be stratified by study group (KTR, HD and GPO patients) and by gender. Correlation coefficients will be reported for each group.

  2. Correlation Between BTM Levels and TBS in KTR compared with HD and GPO patients.

    Time frame: 12 months

    Correlation analysis between BTM levels (procollagen type I N-terminal propeptide (P1NP), osteocalcin, bone specific alkaline phosphatase (BAP), C-terminal telopeptide of type I collagen (CTX) and tartrate-resistant acid phosphatase 5b (TRAP5b)) and TBS (unitless index) derived from DXA images at the lumbar spine. Data will be stratified by study group (KTR, HD and GPO patients) and by gender. Correlation coefficients will be reported for each group.

  3. Key BTMs Predicting Bone Health Outcomes in KTR Patients

    Time frame: 12 months

    Correlation between change from baseline in BTM and change from baseline in TBS.

Study contacts

Contact information is provided by the study sponsor or research team.

Nada Akad, Dr.

CONTACT

[email protected]

0040742015245

Sponsors and collaborators

Lead sponsor

Grigore T. Popa University of Medicine and Pharmacy

Other

Registry information

Official study title

New Directions and Perspectives in the Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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