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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:19 - Any
Updated:4/17/2018
Start Date:December 2003
End Date:September 2014

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

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

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.

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
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Omaha, Nebraska 68198
(402) 559-4000
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