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Effect of alendronate on vascular calcification in CKD stages 3 and 4: a pilot randomized controlled trial
Nigel D Toussaint1, Kenneth K Lau, Boyd J Strauss
1Department of Nephrology, Monash Medical Centre, Clayton, Victoria, Australia. nigel.toussaint@med.monash.edu.au
Insights
Alendronate did not reduce vascular calcification progression in patients with chronic kidney disease (CKD). This study found no significant difference compared to placebo over 18 months.
Area of Science:
- Nephrology
- Cardiovascular Medicine
- Pharmacology
Background:
- Vascular calcification is a significant contributor to cardiovascular disease in chronic kidney disease (CKD) patients.
- Bisphosphonates show potential benefits in experimental models and hemodialysis patients, but their effect in non-dialysis CKD patients is unstudied.
Purpose of the Study:
- To investigate the efficacy of bisphosphonates in mitigating vascular calcification progression in non-dialysis CKD patients.
- To evaluate the impact of alendronate on aortic and femoral artery calcification, arterial compliance, bone mineral density, and renal function.
Main Methods:
- A randomized controlled trial involving 50 patients with CKD stages 3-4, treated with either alendronate (70 mg weekly) or placebo for 18 months.
- Vascular calcification assessed via computed tomography, arterial compliance by pulse wave velocity, and bone mineral density using dual-energy x-ray absorptiometry.
- Intention-to-treat analysis using a random-effect linear regression model to compare outcomes between groups.
Main Results:
- No significant difference in the progression of aortic vascular calcification between the alendronate and placebo groups after 18 months.
- Alendronate treatment led to a significant increase in lumbar spine bone mineral density and a trend towards improved pulse wave velocity.
- No significant differences were observed in femoral bone mineral density or kidney function between the groups.
Conclusions:
- Alendronate did not demonstrate a significant effect on reducing vascular calcification progression in non-dialysis CKD patients over 18 months.
- Limitations including small sample size and baseline differences may have influenced the study's power to detect potential benefits.
- Findings contrast with previous studies in hemodialysis patients, suggesting differing effects of bisphosphonates across CKD populations.
Background:
Vascular calcification contributes to cardiovascular disease in patients with chronic kidney disease (CKD). Few studies have addressed interventions to decrease vascular calcification; however, experimental studies report benefits of bisphosphonates. Recent studies of hemodialysis patients also suggest benefits of bisphosphonates on vascular calcification; however, no study exists in nondialysis patients with CKD.
Study Design:
We conducted a randomized controlled trial to determine the effect of bisphosphonates on vascular calcification in patients with CKD.
Setting & Participants:
51 patients with CKD stages 3-4 were recruited from a hospital outpatient setting; 50 were treated with study medication.
Interventions:
Patients were randomly assigned to either alendronate, 70 mg (n = 25), or matching placebo (n = 25), administered weekly.
Outcomes:
The primary outcome was change in aortic vascular calcification after 18 months. Secondary outcomes included superficial femoral artery vascular calcification, arterial compliance, bone mineral density (BMD), renal function, and serum markers of mineral metabolism.
Measurements:
At baseline and 12 and 18 months, computed tomography, pulse wave velocity using SphygmoCor (AtCor Medical, PWV Inc, www.atcormedical.com), and dual-energy x-ray absorptiometry were performed to measure vascular calcification, arterial compliance, and BMD, respectively. Analysis was by intention to treat, with a random-effect linear regression model to assess differences.
Results:
46 patients completed the study (24 alendronate, 22 placebo); baseline mean age was 63.1 +/- 1.8 years, estimated glomerular filtration rate was 34.5 +/- 1.4 mL/min/1.73 m(2), 59% had diabetes, and 65% were men. 91% had aortic vascular calcification at the start and 78% showed progression. At 18 months, there was no difference in vascular calcification progression with alendronate compared with placebo (adjusted difference, -24.2 Hounsfield units [95% CI, -77.0 to 28.6]; P = 0.4). There was an increase in lumbar spine BMD (T score difference, +0.3 [95% CI, 0.03-0.6]; P = 0.04) and a trend toward better pulse wave velocity (-1 m/s [95% CI, -2.1 to 0.1]; P = 0.07) with alendronate. Femoral BMD was similar between groups. There was a nonsignificant decrease in kidney function in patients on alendronate therapy compared with placebo (-1.2 mL/min/1.73 m(2) [95% CI, -4.0 to 1.7]).
Limitations:
Small sample size and baseline differences, especially with aortic vascular calcification, may have diminished any potential difference between groups.
Conclusions:
Unlike previous studies of hemodialysis patients, alendronate did not decrease the progression of vascular calcification compared with placebo in patients with CKD during 18 months.
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Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.