Treatment with rosuvastatin calcium did not decrease fracture risk among men and women with high levels of the inflammatory biomarker high-sensitivity C-reactive protein (hs-CRP), according to data published in JAMA Internal Medicine.
“Osteoporosis and cardiovascular disease may share common biological pathways, with inflammation playing a role in the development of both. Although observational studies have suggested that statin use is associated with a lower risk of fractures, randomized trial data addressing this issue are scant,” the researchers wrote.
To further investigate this association, Jessica M. Peña, MD, MPH, of the Montefiore Medical Center and Albert Einstein College of Medicine in New York, and colleagues assessed data from the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER).
JUPITER included 17,802 men aged older than 50 years and women aged older than 60 years with hs-CRP level of at least 2 mg/L. Participants were screened from 2003 to 2006 and were followed for a median of 1.9 years.
In the trial, the researchers randomly assigned participants to rosuvastatin calcium 20 mg daily or placebo.
During the study, 431 fractures occurred. There were 221 in the rosuvastatin arm vs. 210 in the placebo arm. Fracture incidence was 1.20 per 100 person-years in the rosuvastatin group vs. 1.14 per 100 person-years in the placebo group (adjusted HR=1.06; 95% CI, 0.88-1.28), according to the study results.
Risk for fracture was higher in women than men (adjusted HR=2.06; 95% CI, 1.66-2.56). In the rosuvastatin group, fracture incidence was 1.80 per 100 person-years (adjusted HR=1.16; 95% CI, 0.89-1.50) for women and 0.85 per 100 person-years (adjusted HR=0.97; 95% CI, 0.74-1.28) for men.
Overall, data demonstrated no association between increasing baseline hs-CRP level and an increased risk for fractures (adjusted HR for each unit increase in hs-CRP tertile=1.06; 95% CI, 0.94-1.20).
The researchers also noted that the effect of rosuvastatin on fracture risk appeared to be consistent across major subgroups, demonstrating no treatment benefit in men or women or in those without a history of previous fracture. Additionally, there was no apparent effect modification by number of previous fractures (P=.73).
“In this large randomized trial of rosuvastatin therapy among men and women with evidence of inflammation, randomization to rosuvastatin did not reduce the risk of fracture and higher baseline hs-CRP level was not associated with an increased risk of fracture,” the researchers concluded.
“Our study does not support the use of statins in doses used for cardiovascular disease prevention to reduce the risk of fracture.”