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Heart TransplantationPhase 2/3CTXNCT00297830

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

A Phase 2/3 study testing Zoledronic acid and Alendronate in people with Heart Transplantation and Liver Transplantation, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 70 years
What is being tested?
Zoledronic acid and Alendronate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
1 siteUnited States
Study dates
Nov 2005to Jan 2014
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A man or woman, aged 20 to 70, of any race who has had a heart or liver transplant

Who cannot join

  • hyperparathyroidism
  • Paget's disease
  • hyperthyroidism
  • cancer
  • severe kidney disease,
  • intestinal disease
Show all 10Show fewer
  • active peptic ulcer disease
  • current or past treatment for osteoporosis
  • pregnancy or lactation
  • severe oral/dental disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

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.

Read the 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.

Being tested
Zoledronic acid, Alendronate, Placebo Zoledronic Acid, Placebo Alendronate
Keywords
Heart Transplantation, Liver Transplantation, Immunosuppression, Bone Density/drug effects, Alendronate, Zoledronic acid, Comparative study, Humans
Medical subject headings
Bone Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zoledronic acidDrug

    Also called Zometa

    Drug is administered through 5 mg intravenous infusion over 20 minutes

  • AlendronateDrug

    Also called Fosamax

    Alendronate 70 mg will be taken once a week in the morning at least 30-60 minutes before first meal

  • Placebo Zoledronic AcidOther

    Infusion of placebo zoledronic acid during the first 5 weeks after transplantation

  • Placebo AlendronateOther

    Placebo alendronate 70 mg once weekly

Study groups in NCT00297830
Study groupRoleWhat they receive
Active Zoledronic Acid & Placebo AlendronateExperimentalGroup 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.
Receives: Drug: Zoledronic acid; Other: Placebo Alendronate
Placebo Zoledronic Acid & Active AlendronateExperimentalGroup 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.
Receives: Drug: Alendronate; Other: Placebo Zoledronic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 12 months

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, 12 months

  2. 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.

    Measured: Baseline, 12 months

  3. Serum N-telopeplide Percent Change

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionApr 2010
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00297830
Sponsor's protocol ID
AAAB2324
Other IDs
CZOL446H104
Acronym
CTX
Status last verified
Jul 2018
First submitted
27 Feb 2006
Last updated
16 Aug 2018
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 14973216

  • 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 Dec;97(12):4481-90. doi: 10.1210/jc.2012-2804. Epub 2012 Sep 28.

    PubMed 23024190

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Zoledronic acid and Alendronate in people with Heart Transplantation and Liver Transplantation, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00297830, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.

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