Osteoporosis Prevention After Heart Transplant
Completed · Phase 3 · Has a placebo group
Conditions studied: Osteoporosis, Cardiac Transplantation
In brief
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.
Key facts
- Study ID
- NCT00000412
- Run by
- Columbia University
- People needed
- 149
- Starts
- 1997-09-01
- Expected to finish
- 2002-04-01
- Last updated by the study team
- 2015-07-07
Who can join
Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Cardiac transplantation
You may not qualify if…
- Active peptic ulcer disease, gastrectomy, inflammatory bowel disease, malignancy, Paget's disease of bone, osteogenesis imperfecta, multiple myeloma, primary hyperparathyroidism, rheumatoid arthritis, Cushing's syndrome, or thyrotoxicosis
- Suppressive doses of thyroid hormone, anticonvulsant drugs, past bisphosphonate therapy, current calcitonin therapy, or fluoride therapy
- Cirrhosis, inflammatory liver disease, or nephrolithiasis
- Serum creatinine > 2.5 mg/dl
Where it is running
- Columbai University Medical Center — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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