1. Based on the results of the trial, there was no difference in the rates of osteoporotic fractures between the group receiving statin therapy compared to the group receiving placebo.
2. Additionally, rising levels of high-sensitivity C-reactive protein (hs-CRP), which is an inflammatory marker related to cardiovascular disease, was not associated with higher incidence of fractures.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Osteoporosis has a significant burden of disease, especially in an aging population. Inflammation plays a major role in not just cardiovascular disease, but also osteoporosis. Statin therapies, which have been mainstays in reducing mortality related to cardiovascular disease, have also been studied in prevention of osteoporosis. This study, the data for which comes from the Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial, sought to determine whether statin therapy was associated with a lower risk of fractures and if higher hs-CRP levels were associated with a greater risk for developing osteoporosis. The results of the study suggested that there was no difference in the rates of fractures between the group receiving stain therapy compared to the one receiving placebo. Additionally, rising levels of hs-CRP did not have any relationship with incidence of fractures.
The JUPITER study has strong internal validity. The results are also generalizable to previously healthy men and women without elevated cholesterol levels. Moreover, the endpoint of osteoporotic fractures was selected a priori. Weaknesses of the study include the relatively short follow-up period, which may not have been able to detect positive outcomes related to osteoporosis, and the fact that a single, fixed-dose of statin was used. Given the negative result of the trial, questions have been raised as to whether the study was adequately powered to detect smaller differences in first fracture rates.
In-Depth [randomized controlled trial]: The data for this study comes from the randomized, double-blind, placebo-controlled, multinational JUPITER trial. One of the pre-specified secondary endpoints of the trial was development of an incident fracture. Relevant inclusion criteria included men and women over ages 50 and 60 years old, respectively, with no history of cardiovascular disease or diabetes mellitus. Exclusion criteria included alcohol abuse, cancer, lupus, severe arthritis, inflammatory bowel disease, use of postmenopausal hormone therapy, or long-term oral glucocorticoid use.
In total, 17,802 participants were included in the study analysis, and the follow-up period was up to five years. The primary endpoint of the original study was related to a cardiovascular event, but an incident fracture was one of the pre-specified secondary endpoints of the study. Study participants were screened from 2003 to 2006, and the study ended in 2008. The investigators performed a multivariable regression model to account for co-morbid conditions and demographic differences. The results of the study showed that the incidence of fracture in the statin and placebo groups were 1.20 and 1.14 per 100 person-years, respectively (HR 1.06; 95%CI 0.88-1.28), showing that there was no significant difference between the two groups. Male and female sex also did not show any differences. There was also no difference between rising hs-CRP and risk of fractures (HR for each unit increase in hs-CRP 1.06; 95%CI 0.94-1.20).
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