NCT00580047

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Zoledronic Acid	4mg IV Annually
COMBINATION_PRODUCT	Calcium with vitamin D	1200 mg Calcium with 800 International Units of vitamin D
DRUG	Alendronate	70mg weekly

Timeline

• Start date: 2003-12-01
• Primary completion: 2014-07-29
• Completion: 2014-07-29
• First posted: 2007-12-24
• Last updated: 2023-10-04
• Results posted: 2018-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study