drugset / Trial / NCT00266708

Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.

NCT00266708

Phase 1/2 Completed 60 enrolled Montefiore Medical Center
RandomizedParallel-groupTriple-blindTreatment

Summary

Patients with kidney failure have underlying bone disease at the time of transplant. Fractures of various bones can be as high as 22%. Medication required for the transplant plays a role in bone loss. Bisphosphonates are used in the general population to treat bone loss of osteoporosis and steroid-induced bone loss. While previous studies, using various bisphosphonates, have shown preservation of bone mineral density in renal transplant recipients, we have demonstrated that pamidronate, a second generation bisphosphonate, is associated with low bone turnover while still preserving bone mineral density. Improved bone mineral density is associated with decreased fracture risk in the general population, while low bone turnover may be associated with increased fracture in dialysis patients. The purpose of this study is to determine whether risedronate, a third generation bisphosphonate, is effective in preserving bone density when given prophylactically following renal transplantation and whether it is associated with low bone turnover at one year following renal transplantation.

Timeline

Start
2002-10
Primary completion
2008-07
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Risedronate Small molecule 35 mg Oral

Indications