Alendronate Versus Denosumab in Kidney Transplant Patients

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Collaborator: Nahda University
• Treatments: Alendronate; Denosumab

Criteria

Inclusion Criteria:

• Adult ≥ 18 year old and medically stable.

• Recent kidney transplantation (up to 3 months).

• Stabilization of renal allograft function.

• Normal liver function.

• Reduced bone mineral density at least one SD lower than normal level for the same age and gender (T-score < -1).

Exclusion Criteria:

• Poor or unstable graft function (creatinine >200 lmol/L).

• Skeletal malignancies or bone metastases.

• Risk for osteosarcoma, such as Paget's disease of the bone.

• Unstable medical condition.

• Pregnancy and lactation.

• Autoimmune diseases.

• Predisposition to drug hypersensitivity.