This trial is active, not recruiting.

Conditions heart transplantation, liver transplantation, bone resorption
Treatments zoledronic acid, alendronate
Phase phase 2/phase 3
Sponsor Columbia University
Collaborator Novartis Pharmaceuticals
Start date November 2005
End date April 2010
Trial size 84 participants
Trial identifier NCT00297830, AAAB2324, CZOL446H104


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
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.
zoledronic acid Zometa
Drug is administered through 5 mg intravenous infusion over 20 minutes
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 Fosamax
Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal

Primary Outcomes

total hip bone mineral density
time frame: 12 months

Secondary Outcomes

lumbar spine bone mineral density
time frame: 12 months
femoral neck bone mineral density
time frame: 12 months
serum n-telopeptide (%)
time frame: 24 months

Eligibility Criteria

Male or female participants from 20 years up to 70 years old.

Inclusion Criteria: - A man or woman, aged 20 to 70, of any race who has had a heart or liver transplant Exclusion Criteria: - hyperparathyroidism - Paget's disease - hyperthyroidism - cancer - severe kidney disease, - intestinal disease - active peptic ulcer disease - current or past treatment for osteoporosis - pregnancy or lactation - severe oral/dental disease

Additional Information

Official title Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Principal investigator Elizabeth Shane, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Columbia University.