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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Elizabeth Shane, Columbia University
ClinicalTrials.gov Identifier:
NCT00297830
First received: February 27, 2006
Last updated: July 28, 2016
Last verified: July 2016

February 27, 2006
July 28, 2016
November 2005
April 2010   (final data collection date for primary outcome measure)
Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
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.
total hip bone mineral density
Complete list of historical versions of study NCT00297830 on ClinicalTrials.gov Archive Site
  • Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    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.
  • Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
    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.
  • Serum N-telopeplide Percent Change [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • lumbar spine bone mineral density
  • femoral neck bone mineral density
  • serum n-telopeptide (%)
Not Provided
Not Provided
 
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Heart Transplantation
  • Liver Transplantation
  • Bone Resorption
  • Drug: Zoledronic acid
    Drug is administered through 5 mg intravenous infusion over 20 minutes
    Other Name: Zometa
  • 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
  • Other: Placebo Zoledronic Acid
    Infusion of placebo zoledronic acid during the first 5 weeks after transplantation
  • Other: Placebo Alendronate
    Placebo alendronate 70 mg once weekly
  • Experimental: Active Zoledronic Acid & Placebo Alendronate
    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.
    Interventions:
    • Drug: Zoledronic acid
    • Other: Placebo Alendronate
  • Experimental: Placebo Zoledronic Acid & Active Alendronate
    Group 2 will receive an infusion of placebo zoledronic acid during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
    Interventions:
    • Drug: Alendronate
    • Other: Placebo Zoledronic Acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
January 2014
April 2010   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00297830
AAAB2324, CZOL446H104
No
Undecided
Not Provided
Elizabeth Shane, Columbia University
Columbia University
Novartis Pharmaceuticals
Principal Investigator: Elizabeth Shane, M.D. Columbia University
Columbia University
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP