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

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2; Phase 1

Conditions: Renal Transplant Osteodystrophy

Treatments: Drug: Placebo; Drug: Risedronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00266708

02-08-224

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Risedronate

Experimental group

Description:

subjects received Risedronate for one year

Treatment:

Drug: Risedronate

subjects received placebo

Placebo Comparator group

Description:

subjects received placebo for 1 year

Treatment:

Drug: Placebo