Expired Study
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Omaha, Nebraska 68198


Purpose:

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


Study summary:

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 compliance and tolerability of taking annual intravenous zoledronic acid versus weekly alendronate in the transplant recipient.


Criteria:

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


NCT ID:

NCT00580047


Primary Contact:

Principal Investigator
Lynn Mack-Shipman, MD
University of Nebraska


Backup Contact:

N/A


Location Contact:

Omaha, Nebraska 68198
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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