drugset / Trial / NCT04169698

Alendronate Versus Denosumab in Kidney Transplant Patients

NCT04169698

Phase 2/3 Completed 90 enrolled Ain Shams University Nahda University · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Alendronic Acid Small molecule 70 mg Oral
Subject Denosumab Monoclonal antibody 60 mg Subcutaneous