Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266708
Status:
COMPLETED
Last Update Posted:
2019-03-01
First Post:
2005-12-15
Brief Title:
Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None