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Phase 2 N=42 Randomized Triple-blind Treatment

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

Renal Transplant Osteodystrophy

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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