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

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ClinicalTrials.gov Identifier: NCT00580047
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Lynn Mack, MD, 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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Drug: Zoledronic Acid Combination Product: Calcium with vitamin D Drug: Alendronate Not Applicable

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  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant
Study Start Date : December 2003
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Zoledronic Acid 4mg intravenously once a year for 2 years
Drug: Zoledronic Acid
4mg IV Annually
Other Name: Zometa
Active Comparator: 2
Alendronate 70mg orally once a week for 2 years
Drug: Alendronate
70mg weekly
Other Name: Fosamax
Placebo Comparator: 3
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



Primary Outcome Measures :
  1. Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant [ Time Frame: 24 months ]
    Percentage Change in Posterior Anterior (PA) spine bone density from baseline to 24 months post transplant


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580047


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Lynn Mack, MD University of Nebraska

Publications:
Responsible Party: Lynn Mack, MD, Associate Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT00580047     History of Changes
Other Study ID Numbers: 437-02-FB
First Posted: December 24, 2007    Key Record Dates
Results First Posted: March 19, 2018
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lynn Mack, MD, University of Nebraska:
bone density
osteopenia
transplant
zoledronic acid
alendronate

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vitamins
Vitamin D
Ergocalciferols
Zoledronic acid
Calcium, Dietary
Diphosphonates
Alendronate
Pancrelipase
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Gastrointestinal Agents
Antacids
Molecular Mechanisms of Pharmacological Action