Original InvestigationPathogenesis and Treatment of Kidney DiseaseEffect of Alendronate on Vascular Calcification in CKD Stages 3 and 4: A Pilot Randomized Controlled Trial
Section snippets
Study Participants
Fifty-one patients were recruited between January and June 2007 from outpatient clinics and private consulting rooms by nephrologists at Monash Medical Centre, Clayton, Australia (Fig 1). Inclusion criteria were age 18-80 years, patients willing to give informed consent, and those with decreased glomerular filtration rate (GFR) of 20-60 mL/min/1.73 m2, estimated using the 4-variable Modification of Diet in Renal Disease (MDRD) Study equation.29 In addition, because alendronate is not
Characteristics of Study Groups
Fifty-one patients were recruited and randomly assigned in this study (Fig 1). One patient who withdrew after randomization and initial investigations, but before the start of study medication, was replaced to maintain treatment allocation in a 1:1 randomization so that 25 patients were allocated to alendronate and 25 were allocated to placebo. During the study period, 2 patients (1 in each group) died of conditions unrelated to the study and 2 were lost to follow-up (both in the placebo group)
Discussion
The present study is the first randomized trial to assess the efficacy of bisphosphonates on decreasing the progression of vascular calcification in the stage 3-4 CKD population. Despite experimental evidence and some clinical studies suggesting that bisphosphonates, potent inhibitors of bone resorption, may decrease the progression of extraosseous calcification and potentially inhibit atherosclerosis, we found no significant difference in the progression of aortic or superficial femoral artery
Acknowledgements
We acknowledge Kate Lyttle (Merck & Co Inc, Australia) for assistance and support with provision of the study medication (alendronate and placebo) and Dr Rory Wolfe (Monash University) for expert statistical advice.
Support: Dr Toussaint is supported by a grant from the National Health and Medical Research Council of Australia. Further information on funding sources is listed in the financial disclosure.
Financial Disclosure: Merck & Co Inc, which markets alendronate, provided support through
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2021, Kidney InternationalCitation Excerpt :Clinical studies evaluating vascular outcomes in patients with CKD are scanty. Although the first-generation bisphosphonate etidronate markedly reduced the progression of vascular calcification in patients with CKD,107 recent generation nitrogen-containing bisphosphonates alendronate and ibandronate demonstrated either improved or unchanged vascular outcomes.79,105,106 In a recent randomized controlled trial, therapy with either alendronate or denosumab for 1 year did not affect indices of vascular health (including vascular calcification scores) in patients on dialysis.79
Originally published online as doi:10.1053/j.ajkd.2009.12.039 on March 29, 2010.
Trial registration: www.ClinicalTrials.gov; study number: NCT00395382