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

Liver Transplantation Clinical Trial

— CTX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297830
• Other study ID #: AAAB2324
• Secondary ID: CZOL446H104
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2005
• Est. completion date: January 2014

Study information

• Verified date: July 2018
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bone Resorption
• Heart Transplantation
• Liver Transplantation

Intervention

Drug:
• Zoledronic acid
Drug is administered through 5 mg intravenous infusion over 20 minutes
• 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
• Placebo Alendronate
Placebo alendronate 70 mg once weekly

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
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