Clinical trial NCT00266708: Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.
Official title: Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Renal Transplant Osteodystrophy
Keywords: renal transplant
post-transplant osteoporosis
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2005-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Bone Mineral Density of Spine at 6 Months
timeFrame: month 6 of the treatment
measure: Bone Mineral Density of Spine at 12 Months
timeFrame: month 12 of treatment
measure: Bone Mineral Density of the Hip at 6 Months
timeFrame: month 6 of the treatment
measure: Bone Mineral Density of the Hip at 12 Months
timeFrame: month 12 of the treatment
measure: Bone Mineral Density of Forearm at 6 Months
timeFrame: month 6 of the treatment
measure: Bone Mineral Density of Forearm at 12 Months
timeFrame: month 12 of the treatment
Secondary outcomes:
measure: Bone Histomorphometry - Percent Bone Volume (BV/TV)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Trabecular Thickness (TbTh)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Mineralized Bone Volume (MdV)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS)
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Bone Formation Rate
timeFrame: Baseline and month 12 of the treatment
measure: Bone Histomorphometry - Osteoid Volume (OV)
timeFrame: Baseline and month 12 of the treatment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Maria Coco, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coco M, Pullman J, Cohen HW, Lee S, Shapiro C, Solorzano C, Greenstein S, Glicklich D. Effect of risedronate on bone in renal transplant recipients. J Am Soc Nephrol. 2012 Aug;23(8):1426-37. doi: 10.1681/ASN.2011060623. Epub 2012 Jul 12.