CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Risedronate +1 moredrug
Likely dose
Risedronate 35 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00266708
NCT00266708Phase 2Completed

Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant

Montefiore Medical Center·interventional·Posted Dec 19, 2005·Updated Mar 1, 2019

In Brief

A Phase 2 clinical trial evaluating Risedronate and Placebo for Renal Transplant Osteodystrophy. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2005
Enrollment StartOct 1, 2002
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.5 years ago

Interventions

Risedronatedrug

risedronate 35 mg weekly

Placebodrug

Risedronate Placebo 35 mg weekly