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NCT07141043Recruiting

Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients

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

Source: ClinicalTrials.gov · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
180 (estimated)
First submitted
28 Jun 2025
Start date
19 Mar 2025
Primary completion date
Dec 2026
Lead sponsor
Grigore T. Popa University of Medicine and Pharmacy
NCT number
NCT07141043

What you commit to

  • Study type: Observational
  • Planned participants: 180
  • From 19 Mar 2025 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • GPO group: The same as for HD + diabetes mellitus + prolonged glucocorticoid therapy (\>7.5 mg Prednisone or equivalent for at least 3 months).

Lab values

  • 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.

Other

  • KTR group: The same as for HD + return to dialysis + acute graft rejection.

Who the study is looking for

  • 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.

Age in the registry: 20 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Medicine and Pharmacy "Grigore T. Popa"
Coordinator of this site? Confirm its status
IașiRomaniaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.