Phase 2
N=42
Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.
Renal Transplant Osteodystrophy
Bottom Line
View on ClinicalTrials.gov: NCT00266708 ↗Enrolled (actual)
42
Serious AEs
2.5%
Results posted
Mar 2019
Primary outcome: Primary: Bone Mineral Density of Spine at 6 Months — 0.98; 0.97 gm/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Risedronate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density of Spine at 6 Months |
0.98; 0.97 | — |
| PRIMARY Bone Mineral Density of Spine at 12 Months |
1.00; 1.00 | — |
| PRIMARY Bone Mineral Density of the Hip at 6 Months |
0.88; 0.86 | — |
| PRIMARY Bone Mineral Density of the Hip at 12 Months |
0.91; 0.87 | — |
| PRIMARY Bone Mineral Density of Forearm at 6 Months |
0.57; 0.58 | — |
| PRIMARY Bone Mineral Density of Forearm at 12 Months |
0.55; 0.58 | — |
| SECONDARY Bone Histomorphometry - Percent Bone Volume (BV/TV) |
10.7; 13.3; 11.3; 9.7 | — |
| SECONDARY Bone Histomorphometry - Trabecular Thickness (TbTh) |
72.6; 90.9; 72.1; 62.2 | — |
| SECONDARY Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV) |
95; 95; 92; 96 | — |
| SECONDARY Bone Histomorphometry - Mineralized Bone Volume (MdV) |
1.2; 1.3; 1.2; 1.0 | — |
| SECONDARY Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume(OV/BV) |
4.1; 4.6; 8.7; 4.9 | — |
| SECONDARY Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV) |
0.49; 0.58; 0.90; 0.51 | — |
| SECONDARY Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS) |
23; 15; 24; 14 | — |
| SECONDARY Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS) |
2.3; 1.3; 1.23; 0.75 | — |
| SECONDARY Bone Histomorphometry - Percent Osteoclasts Relative to Bone Surface (OC/BS) |
1.5; 0.97; 0.28; 0.68 | — |
| SECONDARY Bone Histomorphometry - Percent Eroded Surface Relative to Bone Surface (ES/BS) |
9; 1.36; 2.7; 0.82 | — |
| SECONDARY Bone Histomorphometry - Bone Formation Rate |
0.02; 0.04; 0.10; 0.05 | — |
| SECONDARY Bone Histomorphometry - Osteoid Volume (OV) |
0.06; 0.06; 0.10; 0.03 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults with end stage renal disease who are undergoing living donor kidney transplantation
Data sourced from ClinicalTrials.gov (NCT00266708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.