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Risedronate to Prevent Bone Loss in Renal Transplant
NCT00266708Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2002
- Primary completion
- Jul 2008
- Countries
- 1
- Sponsor
- Montefiore Medical Center
- Modality
- Small Molecules
- Drugs
- risedronate
- Conditions
- renal osteodystrophy
01
Overview
Phase 2, randomised, double-blind trial in renal osteodystrophy comparing Risedronate with Placebo (2 arms). Primary endpoints: Bone Mineral Density of Spine at 12 months, Bone Mineral Density of the Hip at 12 months and 1 more. Started Oct 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Risedronate
Risedronate 35 mg weekly
Placebo
Placebo weekly
03
Endpoints
Primary
Bone Mineral Density of Spine
Bone Mineral Density of the Hip
Bone Mineral Density of Forearm
Secondary
Bone Histomorphometry - Percent Bone Volume (BV/TV)
Bone Histomorphometry - Trabecular Thickness (TbTh)
Bone Histomorphometry - Percent Mineralized Bone Volume (MdV/BV)
Bone Histomorphometry - Mineralized Bone Volume (MdV)
Bone Histomorphometry - Percent Osteoid Volume Relative to Bone Volume (OV/BV)
Bone Histomorphometry - Percent Osteoid Volume Relative to Tissue Volume (OV/TV)
Bone Histomorphometry - Percent Osteoid Surface Relative to Bone Surface (OS/BS)
Bone Histomorphometry - Percent Osteoblasts Relative to Bone Surface (OB/BS)
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