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

September 27, 2023 updated by: University of Nebraska

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 Zoledronic Acid
Zoledronic Acid 4mg intravenously once a year for 2 years
Drug: Zoledronic Acid
4mg IV Annually
Other Names:
  • Zometa
Active Comparator: 2 Alendronate
Alendronate 70mg orally once a week for 2 years
Drug: Alendronate
70mg weekly
Other Names:
  • Fosamax
Placebo Comparator: 3 Placebo
Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily
Combination product: Calcium with vitamin D
1200 mg Calcium with 800 International Units of vitamin D
Other Names:
  • calcium citrate
  • calcium carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
Time Frame: 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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Lynn Mack, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2003

Primary Completion (Actual)

July 29, 2014

Study Completion (Actual)

July 29, 2014

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimated)

December 24, 2007

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0437-02-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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