Phase 3
Completed N=111
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Heart transplantation · Liver Transplantation · Bone Resorption
Source: ClinicalTrials.gov NCT00297830 ↗
Enrolled (actual)
111
Serious AEs
33.3%
Results posted
Sep 2016
Primary outcomePrimary: Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months — 0.39; -0.21; -2.2 percent change
◆ Published Evidence
Established
40citations · ~3 / year
Zoledronic acid versus alendronate for the prevention of bone loss after heart or liver transplantation.
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.
Linked Publications
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Zoledronic acid versus alendronate for the prevention of bone loss after heart or liver transplantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months |
0.39; -0.21; -2.2 | — |
| SECONDARY Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months |
1.98; -0.45; -2.6 | — |
| SECONDARY Percentage Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 12 Months |
0.28; -0.57; -3.3 | — |
| SECONDARY Serum N-telopeplide Percent Change |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00297830) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.