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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-01

Study Completion Date

2014-07-29

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.

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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.

Conditions

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Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Zoledronic Acid

Zoledronic Acid 4mg intravenously once a year for 2 years

Group Type ACTIVE_COMPARATOR

Zoledronic Acid

Intervention Type DRUG

4mg IV Annually

2 Alendronate

Alendronate 70mg orally once a week for 2 years

Group Type ACTIVE_COMPARATOR

Alendronate

Intervention Type DRUG

70mg weekly

3 Placebo

Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily

Group Type PLACEBO_COMPARATOR

Calcium with vitamin D

Intervention Type COMBINATION_PRODUCT

1200 mg Calcium with 800 International Units of vitamin D

Interventions

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Zoledronic Acid

4mg IV Annually

Intervention Type DRUG

Calcium with vitamin D

1200 mg Calcium with 800 International Units of vitamin D

Intervention Type COMBINATION_PRODUCT

Alendronate

70mg weekly

Intervention Type DRUG

Other Intervention Names

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Zometa calcium citrate calcium carbonate Fosamax

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No