N/A N=59 Randomized Treatment

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

Renal Insufficiency

Bottom Line

View on ClinicalTrials.gov: NCT00580047 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2018

Primary outcome: Primary: Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant — 8.1; 6.6; 6.5 percentage of change of bone density

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Zoledronic Acid (Drug); Calcium with vitamin D (Combination_product); Alendronate (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Nebraska
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant	8.1; 6.6; 6.5	—
SECONDARY Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation	100; 80; 80	—

Summary

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

Eligibility 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 3.0
Patients already treated with bisphosphonates within the past one year
Patients unable to undergo DXA
Patients with cancer

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00580047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.