drugset / Trial / NCT00000412

Osteoporosis Prevention After Heart Transplant

NCT00000412

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
1997-09
Primary completion
2002-04
Completion
2002-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alendronic Acid Small molecule 10 mg
Comparator Calcitriol Small molecule 0.25 ug

Indications