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

Primary Purpose

Renal Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zoledronic Acid
Calcium with vitamin D
Alendronate
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency focused on measuring bone density, osteopenia, transplant, zoledronic acid, alendronate

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1 Zoledronic Acid

2 Alendronate

3 Placebo

Arm Description

Zoledronic Acid 4mg intravenously once a year for 2 years

Alendronate 70mg orally once a week for 2 years

Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily

Outcomes

Primary Outcome Measures

Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
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

Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation
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.

Full Information

First Posted
December 17, 2007
Last Updated
September 27, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT00580047
Brief Title
Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants
Official Title
Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2003 (Actual)
Primary Completion Date
July 29, 2014 (Actual)
Study Completion Date
July 29, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
bone density, osteopenia, transplant, zoledronic acid, alendronate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Zoledronic Acid
Arm Type
Active Comparator
Arm Description
Zoledronic Acid 4mg intravenously once a year for 2 years
Arm Title
2 Alendronate
Arm Type
Active Comparator
Arm Description
Alendronate 70mg orally once a week for 2 years
Arm Title
3 Placebo
Arm Type
Placebo Comparator
Arm Description
Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Other Intervention Name(s)
Zometa
Intervention Description
4mg IV Annually
Intervention Type
Combination Product
Intervention Name(s)
Calcium with vitamin D
Other Intervention Name(s)
calcium citrate, calcium carbonate
Intervention Description
1200 mg Calcium with 800 International Units of vitamin D
Intervention Type
Drug
Intervention Name(s)
Alendronate
Other Intervention Name(s)
Fosamax
Intervention Description
70mg weekly
Primary Outcome Measure Information:
Title
Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Mack, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26733377
Citation
Wang J, Yao M, Xu JH, Shu B, Wang YJ, Cui XJ. Bisphosphonates for prevention of osteopenia in kidney-transplant recipients: a systematic review of randomized controlled trials. Osteoporos Int. 2016 May;27(5):1683-90. doi: 10.1007/s00198-015-3465-7. Epub 2016 Jan 5.
Results Reference
background
PubMed Identifier
23024190
Citation
Shane E, Cohen A, Stein EM, McMahon DJ, Zhang C, Young P, Pandit K, Staron RB, Verna EC, Brown R, Restaino S, Mancini D. Zoledronic acid versus alendronate for the prevention of bone loss after heart or liver transplantation. J Clin Endocrinol Metab. 2012 Dec;97(12):4481-90. doi: 10.1210/jc.2012-2804. Epub 2012 Sep 28.
Results Reference
background

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

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