Phase 3
N=111
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
Heart Transplantation · Liver Transplantation · Bone Resorption
Bottom Line
View on ClinicalTrials.gov: NCT00297830 ↗Enrolled (actual)
111
Serious AEs
33.3%
Results posted
Sep 2016
Primary outcome: Primary: Percentage Change From Baseline in Total Hip Bone Mineral Density (BMD) at 12 Months — 0.39; -0.21; -2.2 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic acid (Drug); Alendronate (Drug); Placebo Zoledronic Acid (Other); Placebo Alendronate (Other)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Apr 2010
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 |
— | — |
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.
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). 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.