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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Elizabeth Shane, Columbia University
ClinicalTrials.gov Identifier:
NCT00297830
First received: February 27, 2006
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Transplantation
Liver Transplantation
Bone Resorption
 Drug: zoledronic acid
Drug: alendronate
 Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • total hip bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 84
Study Start Date: November 2005
Estimated Study Completion Date: January 2014
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Experimental: 2
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.
 Drug: alendronate
Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal
Other Name: Fosamax

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297830

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Novartis Pharmaceuticals
Investigators
Principal Investigator: Elizabeth Shane, M.D. Columbia University
  More Information

Publications:

Responsible Party: Elizabeth Shane, Professor of Medicine, Endocrinology, Columbia University
ClinicalTrials.gov Identifier: NCT00297830     History of Changes
Other Study ID Numbers: AAAB2324, CZOL446H104
Study First Received: February 27, 2006
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Heart Transplantation
Liver Transplantation
Immunosuppression
Bone Density/drug effects
 Alendronate
Zoledronic acid
Comparative study
Humans

Additional relevant MeSH terms:
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Alendronate
 Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013