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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: Completed Phase 1 study, sponsored by Montefiore Medical Center.
NCT00266708 is a Phase 1 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Bone Mineral Density (BMD) measurements were of the vertebral spine (L1-L4) measured using the Hologic 4500 QDC scanner.
Interventions
- DRUG Placebo
- DRUG Risedronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-10 |
| Est. Completion | 2008-07 |
| Phase | Phase 1 |
What the finished NCT00266708 record still lists
NCT00266708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00266708 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00266708's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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