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

University of Nebraska59 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Insufficiency

Interventions

Zoledronic AcidDRUG

4mg IV Annually

Calcium with vitamin DCOMBINATION_PRODUCT

1200 mg Calcium with 800 International Units of vitamin D

AlendronateDRUG

70mg weekly

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

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

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.

Time frame: 24 months

Secondary Outcomes

Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation

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.

Time frame: 24 months

Data from ClinicalTrials.gov

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