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.
Phase:
Phase 3
Details
Lead Sponsor:
Columbia University
Collaborators:
Merck Sharp & Dohme Corp. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)