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

Not Applicable

Completed

• Conditions: Renal Insufficiency
• Interventions: Drug: Zoledronic Acid; Combination Product: Calcium with vitamin D; Drug: Alendronate

• Registration Number: NCT00580047
• Lead Sponsor: University of Nebraska

Brief 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.

Study Timeline

• Study Start: 2003-12-01
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-24
• Primary Completion: 2014-07-29
• Study Completion: 2014-07-29
• Results First Submitted: 2016-01-18
• Results First Submitted QC: 2018-03-15
• Results First Posted: 2018-03-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Zoledronic Acid	Zoledronic Acid	Zoledronic Acid 4mg intravenously once a year for 2 years
3 Placebo	Calcium with vitamin D	Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily
2 Alendronate	Alendronate	Alendronate 70mg orally once a week for 2 years

Primary Outcome Measures

Name	Time	Method
Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant	24 months	Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant.

Secondary Outcome Measures

Name	Time	Method
Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation	24 months	Compare compliance where a study coordinator interviewed patients as to how often they missed the once a week oral alendronate, missed taking calcium and vitamin D supplementation, or missed the once a year IV Reclast.

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States