This trial is active, not recruiting.

Condition renal insufficiency
Treatments zoledronic acid, calcium and vitamin d, alendronate
Sponsor University of Nebraska
Start date December 2003
End date March 2014
Trial size 110 participants
Trial identifier NCT00580047, 437-02-FB


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Zoledronic Acid 4mg
zoledronic acid Zometa
4mg IV Annually
(Active Comparator)
Alendronate 70mg
alendronate Fosamax
70mg weekly
(Placebo Comparator)
Calcium 1200mg Vitamin D 800IU
calcium and vitamin d calcium citrate
1200 mg Calcium 800 International Units Vitamin D

Primary Outcomes

Percent change in Posterior Anterior (PA) spine bone density from baseline to 24 months post transplant
time frame: 2 years

Secondary Outcomes

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
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

Male or female participants at least 19 years old.

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

Additional Information

Official title Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant
Principal investigator Lynn Mack-Shipman, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Nebraska.