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Sponsored by: |
Montefiore Medical Center |
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Information provided by: | Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT00266708 |
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.
Condition | Intervention |
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Renal Transplant Osteodystrophy |
Drug: risedronate 35 mg weekly vs placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant |
Estimated Enrollment: | 60 |
Study Start Date: | October 2002 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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 DEXA bone mineral density scans. Both groups undergo bone hormonal studies at regular intervals.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Maria Coco, MD, MS | Montefiore Medical Center |
Study ID Numbers: | 02-08-224 |
Study First Received: | December 15, 2005 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00266708 History of Changes |
Health Authority: | United States: Institutional Review Board |
renal transplant post-transplant osteoporosis |
Calcium, Dietary Calcium Channel Blockers Osteoporosis |
Bone Density Conservation Agents Cardiovascular Agents Risedronic acid |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Calcium Channel Blockers |
Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions Risedronic acid |