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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 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 149 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000412
The ClinicalTrials.gov registry entry for NCT00000412 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Alendronate is the first listed.
NCT00000412 reports 0 study locations.
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.
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