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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Renal Transplant Osteodystrophy

In brief

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.

Key facts

Study ID

NCT00266708

Run by

Montefiore Medical Center

People needed

60

Starts

2002-10-01

Expected to finish

2008-07-01

Last updated by the study team

2019-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults with end stage renal disease who are undergoing living donor kidney transplantation

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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