Liver Transplantation Clinical Trial
— CTXOfficial title:
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Verified date | July 2018 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 111 |
Est. completion date | January 2014 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Novartis Pharmaceuticals |
United States,
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. — View 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 — View Citation
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---|---|---|---|---|
Primary | Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months | BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer. | Baseline, 12 months | |
Secondary | Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months | BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer. | Baseline, 12 months | |
Secondary | Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months | BMD was measured by dual-energy x-ray absorptiometry (QDR-4500 densitometer; Hologic, Inc., Bedford, MA); short-term in vivo coefficient of variation is 0.68% (spine) and 1.36% (femoral neck). T scores were generated using gender-specific databases provided by the manufacturer. | Baseline, 12 months | |
Secondary | Serum N-telopeplide Percent Change | 24 months |
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