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NCT00266708 · ClinicalTrials.gov registry record · Phase 1
Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.
A Phase 1 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00266708 is a Phase 1 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 60 participants.
The verdict
NCT00266708, a Phase 1 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Risedronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-10 |
| Est. Completion | 2008-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00266708
The ClinicalTrials.gov registry entry for NCT00266708 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00266708 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00266708 about?
NCT00266708 is a clinical study titled "Randomized Trial of Risedronate to Prevent Bone Loss in Renal Transplant Recipients.". 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-...
What is the current status of trial NCT00266708?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2002-10. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00266708?
The interventions under investigation include: Placebo (DRUG), Risedronate (DRUG).
Who is sponsoring clinical trial NCT00266708?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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