Clinical trial NCT00297830
Conditions: Heart Transplantation Liver Transplantation Bone Resorption
Keywords: Heart Transplantation Liver Transplantation Immunosuppression Bone Density/drug effects Alendronate Zoledronic acid Comparative study Humans
Sponsor: Columbia University
Start date: 2005-11-01; Completion date: 2014-01-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness and safety of zoledronic acid with alendronate in the prevention of bone loss after organ transplantation. Zoledronic acid is given as a single intravenous infusion. Alendronate is given as a weekly pill. Both are expected to be very effective, but it is not known which one will work best.

Detailed description:
Patients who have undergone heart or liver transplantation are usually required to remain on medications, such as Prednisone and Cyclosporine A or Tacrolimus, that prevent the body from rejecting the transplanted organ. These medications may cause bone loss which leads to thinning of the bones (osteoporosis) and therefore greatly increase the risk of having broken bones (fractures) after transplantation. Several published studies have shown that 14% to 35% of heart transplant patients develop fractures (spine, ribs and hip) during the first year after transplantation. We have previously shown that alendronate (Fosamax), a drug approved by the FDA for prevention and treatment of postmenopausal osteoporosis and prednisone-induced osteoporosis, prevents bone loss after heart transplantation. We are conducting this study to determine whether a newer drug, zoledronic acid, is as effective as alendronate.

This study is a randomized, double-blind, placebo-controlled 2-year study. Participants will receive one dose of active zoledronic acid during the first month after heart or liver transplantation and weekly placebo alendronate pills or one dose of placebo zoledronic acid and weekly active alendronate pills for the first year after transplant. Over 2 years, participants will provide blood samples on nine occasions. Bone density will be performed 4-5 times and spine xrays will be performed twice.

Arms: arm 1: Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion. arm 2: Group 2 will receive an infusion of placebo zoledronic acid during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
Interventions: intervention 1: Zoledronic acid intervention 2: Alendronate intervention 3: Placebo Zoledronic Acid intervention 4: Placebo Alendronate
Intervention descriptions: intervention 1: Drug is administered through 5 mg intravenous infusion over 20 minutes intervention 2: Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal intervention 3: Infusion of placebo zoledronic acid during the first 5 weeks after transplantation intervention 4: Placebo alendronate 70 mg once weekly

Protocol documents: