NCT00266708

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

Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants who receive a living donor kidney transplant undergo a bone biopsy at the time of kidney transplant and after one year of protocol. Once adequate kidney function is established, both groups take by mouth a weekly capsule (the control group has a placebo; the treatment group has risedronate 35 mg). Both groups undergo baseline, 6 month and 12 month dual energy x-ray absorptiometry (DEXA) bone mineral density scans. Both groups undergo bone hormonal studies at regular intervals.

Conditions

• Renal Transplant Osteodystrophy

Interventions

Type	Name	Description
DRUG	Risedronate	risedronate 35 mg weekly
DRUG	Placebo	Risedronate Placebo 35 mg weekly

Timeline

• Start date: 2002-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2005-12-19
• Last updated: 2019-03-01
• Results posted: 2019-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study