Osteoporosis Prevention After Heart Transplant

Launched by COLUMBIA UNIVERSITY · Nov 3, 1999

Keywords

ClinConnect Summary

We will enroll patients who have undergone cardiac transplantation into a randomized, double-blind, 12-month study of the efficacy and safety of calcitriol (Rocaltrol) and alendronate sodium (Fosamax) in the prevention of bone loss after transplantation. We will give all participants standard pre- and post-transplantation management and immunosuppressive therapy, three tablets of calcium citrate (Citracal + D, each containing 315 mg of elemental calcium and 200 IU of vitamin D), and a multivitamin providing 400 units of vitamin D daily. We will randomize participants to one of two active tr...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Cardiac transplantation
• Exclusion Criteria:
• • 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

Trial Officials