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

This study is currently recruiting participants.
Verified by University of Nebraska, December 2007

Sponsored by: University of Nebraska
Information provided by: University of Nebraska
ClinicalTrials.gov Identifier: NCT00580047
  Purpose

The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.


Condition Intervention
Renal Insufficiency
Drug: Zoledronic Acid
Drug: calcium and Vitamin D
Drug: Alendronate

MedlinePlus related topics:   Pancreas Transplantation   

ChemIDplus related topics:   Alendronate    Alendronate sodium    Zoledronic acid    Calcium gluconate    Citric acid    Sodium Citrate    Vitamin D    Ergocalciferol    Calcium citrate    Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Percent change in PA spine bone density from baseline to 24 months post transplant [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   110
Study Start Date:   December 2003
Estimated Study Completion Date:   December 2009

Arms Assigned Interventions
1: Active Comparator
Zoledronic Acid 4mg
Drug: Zoledronic Acid
4mg IV Annually
2: Active Comparator
Alendronate 70mg
Drug: Alendronate
70mg weekly
3: Placebo Comparator
Calcium 1200mg Vitamin D 800IU
Drug: calcium and Vitamin D
1200mg Calcium 800IU Vitamin D

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580047

Contacts
Contact: LuAnn Larson, RN, BSN     402-559-8555 ext email     llarson@unmc.edu    
Contact: Claire Haire, RN, MSN     402-559-5955 ext email     chaire@unmc.edu    

Locations
United States, Nebraska
University of Nebraska Medical Center     Recruiting
      Omaha, Nebraska, United States, 68198
      Contact: Lynn Mack-Shipman, MD     405-559-6205 ext email     lmack@unmc.edu    
      Principal Investigator: Lynn Mack-Shipman, MD            

Sponsors and Collaborators
University of Nebraska

Investigators
Principal Investigator:     Lynn Mack-Shipman, MD     University of Nebraska    
  More Information


Responsible Party:   University of Nebraska Medical Center ( Lynn Mack-Shipman, M.D. )
Study ID Numbers:   437-02FB
First Received:   December 17, 2007
Last Updated:   December 21, 2007
ClinicalTrials.gov Identifier:   NCT00580047
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Nebraska:
bone density  
osteopenia  
transplant  
zoledronic acid  
alendronate  

Study placed in the following topic categories:
Renal Insufficiency
Diphosphonates
Vitamin D
Zoledronic acid
Urologic Diseases
Alendronate
Citric Acid
Ergocalciferols
Kidney Diseases
Pancrelipase

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008




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