Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
CTX
2 other identifiers
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2005
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
September 15, 2016
CompletedAugust 16, 2018
July 1, 2018
4.4 years
February 27, 2006
February 15, 2013
July 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Baseline, 12 months
Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months
Baseline, 12 months
Serum N-telopeplide Percent Change
24 months
Study Arms (2)
Active Zoledronic Acid & Placebo Alendronate
EXPERIMENTALGroup 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.
Placebo Zoledronic Acid & Active Alendronate
EXPERIMENTALGroup 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 is administered through 5 mg intravenous infusion over 20 minutes
Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal
Infusion of placebo zoledronic acid during the first 5 weeks after transplantation
Placebo alendronate 70 mg once weekly
Eligibility Criteria
You may qualify if:
- A man or woman, aged 20 to 70, of any race who has had a heart or liver transplant
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Novartis Pharmaceuticalscollaborator
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related 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. doi: 10.1056/NEJMoa035617.
PMID: 14973216BACKGROUNDShane 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.
PMID: 23024190RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Heart and liver transplant recipients differ in pretransplant bone disease and exposure to prednisone. Not powered to detect differences in fracture rates,an important clinical outcome,one that would require a large comparative effectiveness trial.
Results Point of Contact
- Title
- Dr. Elizabeth Shane
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Shane, M.D.
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Endocrinology
Study Record Dates
First Submitted
February 27, 2006
First Posted
March 1, 2006
Study Start
November 1, 2005
Primary Completion
April 1, 2010
Study Completion
January 1, 2014
Last Updated
August 16, 2018
Results First Posted
September 15, 2016
Record last verified: 2018-07