Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients

NCT07141043 | Recruiting

• 1 other identifier: Nr. 501/30.11.2024
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodyalysis; Kidney Tansplant; Osteoporosis; CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder

Keywords

CKD-MBD; Osteoporosis; bone turnover markers

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months

Secondary Outcomes (3)

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

  12 months

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

  12 months

• Key BTMs Predicting Bone Health Outcomes in KTR Patients

  12 months

Study Arms (3)

Hemodialysis group

Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent.

Kidney transplant 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.

General population osteoporosis/osteopenia

Men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old and patients undergoing HD or KTR, aged 20-70 years old.

You may qualify if:

• HD group: Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent.
• GPO group: men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

University of Medicine and Pharmacy "Grigore T. Popa"

Iași, Romania

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Osteoporosis; Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Rickets; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nada Akad, Dr.

CONTACT

0040742015245; akadnada@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: August 26, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)