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Sponsored by: |
University of Nebraska |
Information provided by: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT00580047 |
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 |
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 |
Estimated Enrollment: | 110 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | December 2009 |
Arms | Assigned Interventions |
1: Active Comparator
Zoledronic Acid 4mg
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Drug: Zoledronic Acid
4mg IV Annually
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2: Active Comparator
Alendronate 70mg
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Drug: Alendronate
70mg weekly
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3: Placebo Comparator
Calcium 1200mg Vitamin D 800IU
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Drug: calcium and Vitamin D
1200mg Calcium 800IU Vitamin D
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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.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
University of Nebraska |
Principal Investigator: | Lynn Mack-Shipman, MD | University of Nebraska |
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 |
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