NCT00297830

Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Transplantation
• Liver Transplantation
• Bone Resorption

Interventions

Type	Name	Description
DRUG	Zoledronic acid	Drug is administered through 5 mg intravenous infusion over 20 minutes
DRUG	Alendronate	Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal
OTHER	Placebo Zoledronic Acid	Infusion of placebo zoledronic acid during the first 5 weeks after transplantation
OTHER	Placebo Alendronate	Placebo alendronate 70 mg once weekly

Timeline

• Start date: 2005-11-01
• Primary completion: 2010-04-01
• Completion: 2014-01-01
• First posted: 2006-03-01
• Last updated: 2018-08-16
• Results posted: 2016-09-15

Locations

1 site across 1 country: United States