Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

The aim are to determin 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 follow for two years with annual bone density testing as well as biochemical markers. A secondary aim is to evaluate compliance and tolerability oftaking annual intravenous zoledronic acid versus weekly alendronate in the transplant recipient.

Intervention(s) in this Clinical Trial

• Drug: Zoledronic Acid
  • 4mg IV Annually
• Drug: calcium and Vitamin D
  • 1200mg Calcium 800IU Vitamin D
• Drug: Alendronate
  • 70mg weekly

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Zoledronic Acid 4mg
• Active Comparator: 2
  • Alendronate 70mg
• Placebo Comparator: 3
  • Calcium 1200mg Vitamin D 800IU

Primary Measures

• Percent change in PA spine bone density from baseline to 24 months post transplant
  • Time Frame: 2 years
    Safety Issue?: No

Secondary Measures

• Percent change in PA spine bone density from baseline to 12 months and percent change in total hip bone density from baselint to 24 months
  • Time Frame: 12 months
    Safety Issue?: No
• Patient compliance will be quantified in the alendronate and placebo groups asthe percewntage of pills distributed that were taken. The occurence of side effects will be summarized using descriptive statistics and compared among the treatment groups.
  • Time Frame: 2 years
    Safety Issue?: Yes

Inclusion Criteria:

• Transplant patients who have had a kidney or kidney/pancreas transplant in the last 150 days with adequate kidney function as defiened by a calculated creatine cleanace of 35ml/min or more and serum creatinine less than 3.0

Exclusion Criteria:

• DXA T-score at the spine or hip of -3 or lower
• History of more than one vertebral or nonvertebral fracture in the past two years
• Abnormalities of the esophagus whic delay esphageal emptying
• Inability to stay upright for 30 minutes
• Pregnant, nursing women or women not using an efective form of birth control
• Hypocalcemia
• Hypercalcemia
• Calculated creatinine clearnace of <35 ml/min or serum creatinine > 3.0
• Patients already treated with bisphosphonates witnin the past one year
• Patients unable to undergo DXA
• Patients with cancer

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Nebraska

Overall Clinical Trial Officials and Contacts

Lynn Mack-Shipman, MD Principal Investigator University of Nebraska  

Overall Contact: LuAnn Larson, RN, BSN 402-559-8555 llarson@unmc.edu

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00580047

Study ID Number: 437-02FB

ClinicalTrials.gov Identifier: NCT00580047

Health Authority: United States: Institutional Review Board