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NCT00000412 · ClinicalTrials.gov registry record · Phase 3
Osteoporosis Prevention After Heart Transplant
A Phase 3 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 3
- Development phase
- 149
- Enrollment target
NCT00000412: Completed Phase 3 study, sponsored by Columbia University.
NCT00000412 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 149 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000412, a Phase 3 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 149 participants
- Enrollment target
Study Summary
During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
Interventions
- DRUG Alendronate
- DRUG Calcitriol
- DRUG Placebo Alendronate
- DRUG Placebo Calcitriol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 1997-09 |
| Est. Completion | 2002-04 |
| Phase | Phase 3 |
What the finished NCT00000412 record still lists
NCT00000412 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 4 interventions - of which Alendronate is the first listed.
NCT00000412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000412 about?
NCT00000412 is a clinical study titled "Osteoporosis Prevention After Heart Transplant". During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug al...
What is the current status of trial NCT00000412?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 149 participants. The study started on 1997-09. Estimated completion is 2002-04.
What interventions are being tested in trial NCT00000412?
The interventions under investigation include: Alendronate (DRUG), Calcitriol (DRUG), Placebo Alendronate (DRUG), Placebo Calcitriol (DRUG).
Who is sponsoring clinical trial NCT00000412?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000412's enrollment target sits among peer trials
149 1546th of 2000 higher than 454 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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