Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation (CTX)
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.
Drug: zoledronic acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
|Official Title:||Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation|
- total hip bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- lumbar spine bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- femoral neck bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- serum n-telopeptide (%) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
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.
Drug: zoledronic acid
Drug is administered through 5 mg intravenous infusion over 20 minutes
Other Name: Zometa
Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal
Other Name: Fosamax
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297830
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Elizabeth Shane, M.D.||Columbia University|