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Alendronate Versus Denosumab in Kidney Transplant Patients

NCT04169698 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-11-12

No results posted yet for this study

Summary

The management of bone disease has often been neglected post-transplantation, when the clinical focus is on allograft function and immunological sequelae. However, most renal transplant recipients (RTRs) have pre-existing CKD-MBD, which results in changes to mineral metabolism and reduced bone mineral density (BMD) and quality, which are linked to an increased incidence of fractures and cardiovascular disease. Bone loss is greatest in the first 6-12 months post-transplantation, during which period any intervention is likely to be of greatest benefit. Anti-resorptive agents all inhibit bone resorption. Since bisphosphonates and densoumab are the most widely used anti-resorptive agents for osteoporosis, we conduct this prospective interventional comparative study to compare the efficacy and tolerability of alendronate versus denosumab in de novo kidney transplant recipients with reduced bone mineral density, in the first 12 months treatment after kidney transplantation.

Conditions

  • Osteoporosis, Osteopenia
  • Renal Transplant Recipient

Interventions

DRUG

Denosumab 60 mg/ml [Prolia]

full length human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand

DRUG

Alendronate 70Mg Tab

Bisphosphonates

Sponsors & Collaborators

  • Nahda University

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Sherihan A Omar · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2021-05-01
Completion
2021-05-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169698 on ClinicalTrials.gov