Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

CKD-MBDOsteoporosisbone 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

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

Age20 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Grigore T. Popa University of Medicine and Pharmacy
Otherlead

Study Sites (1)

University of Medicine and Pharmacy "Grigore T. Popa"

Iași, Romania

RECRUITING

Nada Akad, Dr.CONTACTakadnada@gmail.com

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

OsteoporosisChronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesRicketsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalcium Metabolism Disorders

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

Actual (reported)

Primary Completion

December 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Hemodialysis group

Kidney transplant group

General population osteoporosis/osteopenia

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Hemodialysis group

Kidney transplant group

General population osteoporosis/osteopenia

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations