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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 : Unknown
Verified January 2014 by Lynn Mack, MD, University of Nebraska.
Recruitment status was:  Active, not recruiting
First Posted : December 24, 2007
Last Update Posted : January 3, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Renal Insufficiency Drug: Zoledronic Acid Drug: calcium and Vitamin D Drug: Alendronate

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 compliance and tolerability of taking annual intravenous zoledronic acid versus weekly alendronate in the transplant recipient.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Single Group 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
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Zoledronic Acid 4mg
Drug: Zoledronic Acid
4mg IV Annually
Other Name: Zometa
Active Comparator: 2
Alendronate 70mg
Drug: Alendronate
70mg weekly
Other Name: Fosamax
Placebo Comparator: 3
Calcium 1200mg Vitamin D 800IU
Drug: calcium and Vitamin D
1200 mg Calcium 800 International Units Vitamin D
Other Name: calcium citrate


Outcome Measures

Primary Outcome Measures :
  1. Percent change in Posterior Anterior (PA) spine bone density from baseline to 24 months post transplant [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Percent change in PA spine bone density from baseline to 12 months and percent change in total hip bone density from baseline to 24 months [ Time Frame: 12 months ]
  2. Patient compliance will be quantified in the alendronate and placebo groups as the percentage 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 ]

Eligibility Criteria

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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
Contacts and Locations

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-Shipman, MD University of Nebraska
More Information

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
Last Update Posted: January 3, 2014
Last Verified: January 2014

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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Gastrointestinal Agents