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Completed

NCT Number: NCT00580047

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

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

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Key information

Conditions

Renal Insufficiency Bone Diseases Bone Diseases, Metabolic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic acid

Drug

4mg IV Annually

Other names: Zometa

Calcium with vitamin D

Combination Product

1200 mg Calcium with 800 International Units of vitamin D

Other names: calcium citrate, calcium carbonate

Alendronate

Drug

70mg weekly

Other names: Fosamax

Primary outcomes

  1. Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant

    Time frame: 24 months

    Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2007
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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