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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lynn Mack, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00580047
First received: December 17, 2007
Last updated: January 2, 2014
Last verified: January 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Percent change in Posterior Anterior (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 baseline to 24 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: December 2003
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Lynn Mack, MD, Associate Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT00580047     History of Changes
Other Study ID Numbers: 437-02-FB
Study First Received: December 17, 2007
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Zoledronic acid
Calcium, Dietary
Vitamin D
Ergocalciferols
Alendronate
Diphosphonates
Vitamins
Pancrelipase
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014