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

University of Nebraska

Status: Completed

Conditions: Renal Insufficiency

Treatments: Drug: Alendronate; Drug: Zoledronic Acid; Combination Product: Calcium with vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT00580047

0437-02-FB

Details and patient eligibility

About

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

Full 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 the compliance.

Enrollment: 59 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 3 patient groups, including a placebo group

1 Zoledronic Acid

Active Comparator group

Description:

Zoledronic Acid 4mg intravenously once a year for 2 years

Treatment:

Drug: Zoledronic Acid

2 Alendronate

Active Comparator group

Description:

Alendronate 70mg orally once a week for 2 years

Treatment:

Drug: Alendronate

3 Placebo

Placebo Comparator group

Description:

Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily

Treatment:

Combination Product: Calcium with vitamin D