Clinical trial NCT00297830: Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Official title: Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Transplantation
Liver Transplantation
Bone Resorption
Keywords: Heart Transplantation
Liver Transplantation
Immunosuppression
Bone Density/drug effects
Alendronate
Zoledronic acid
Comparative study
Humans
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2006-03-01
Enrollment: 111
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
timeFrame: Baseline, 12 months
measure: Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months
timeFrame: Baseline, 12 months
measure: Serum N-telopeplide Percent Change
timeFrame: 24 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Elizabeth Shane, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shane E, Addesso V, Namerow PB, McMahon DJ, Lo SH, Staron RB, Zucker M, Pardi S, Maybaum S, Mancini D. Alendronate versus calcitriol for the prevention of bone loss after cardiac transplantation. N Engl J Med. 2004 Feb 19;350(8):767-76. doi: 10.1056/NEJMoa035617.
citation: Shane E, Cohen A, Stein EM, McMahon DJ, Zhang C, Young P, Pandit K, Staron RB, Verna EC, Brown R, Restaino S, Mancini D. Zoledronic acid versus alendronate for the prevention of bone loss after heart or liver transplantation. J Clin Endocrinol Metab. 2012 Dec;97(12):4481-90. doi: 10.1210/jc.2012-2804. Epub 2012 Sep 28.