Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants

Study Overview
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Brief Summary
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The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.

Detailed Description
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The aims are to determine baseline bone mineral density (BMD) in kidney and kidney/pancreas transplant patients who will be randomized to weekly alendronate, annual zoledronic acid infusions or placebo (calcium with Vitamin D). These patients will be followed for two years with annual bone density testing as well as biochemical markers. A secondary aim is to evaluate the compliance.

Official Title
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Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Drug: Zoledronic Acid
* Combination Product: Calcium with vitamin D
* Drug: Alendronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Transplant patients who have had a kidney or kidney/pancreas transplant in the last 150 days with adequate kidney function as defined by a calculated creatine clearance of 35ml/min or more and serum creatinine less than 3.0 Exclusion Criteria: Dual X-ray Absorptiometry (DXA) T-score at the spine or hip of -3 or lower History of more than one vertebral or non-vertebral fracture in the past two years Abnormalities of the esophagus which delay esophageal emptying Inability to stay upright for 30 minutes Pregnant, nursing women or women not using an effective form of birth control Hypocalcemia Hypercalcemia Calculated creatinine clearance of <35 ml/min or serum creatinine > 3.0 Patients already treated with bisphosphonates within the past one year Patients unable to undergo DXA Patients with cancer

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Zoledronic Acid<br>Zoledronic Acid 4mg intravenously once a year for 2 years | Drug: Zoledronic Acid<br>* 4mg IV Annually<br>* Other names: Zometa;|
| Active Comparator: 2 Alendronate<br>Alendronate 70mg orally once a week for 2 years | Drug: Alendronate<br>* 70mg weekly<br>* Other names: Fosamax;|
| Placebo Comparator: 3 Placebo<br>Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily | Combination Product: Calcium with vitamin D<br>* 1200 mg Calcium with 800 International Units of vitamin D<br>* Other names: calcium carbonate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant | Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation | Compare compliance where a study coordinator interviewed patients as to how often they missed the once a week oral alendronate, missed taking calcium and vitamin D supplementation, or missed the once a year IV Reclast. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone density, osteopenia, transplant, zoledronic acid, alendronate