Daily rosuvastatin did not decrease fracture risk in a large international clinical trial involving older men and women who had elevated CRP levels, according to a report published online Dec. 1 in JAMA Internal Medicine.
Statins are thought to stimulate bone formation and increase bone mineral density, suggesting that they may exert clinical benefits beyond cardiovascular disease (CVD) prevention. Several observational studies have reported that statin users show a decreased risk of osteoporotic fractures, compared with nonusers. To examine this possible benefit, the JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial enrolled 17,802 men older than 50 years and women older than 60 years to receive either rosuvastatin or matching placebo and be followed for up to 5 years (median follow-up, 2 years) for both CVD and fracture events. The study was conducted at 1,315 medical centers in 26 countries, said Dr. Jessica M. Peña of the division of cardiology, Montefiore Medical Center, New York, and her associates.
A total of 431 participants sustained fractures: 221 in the rosuvastatin group and 210 in the placebo group, a nonsignificant difference. The corresponding rate of fracture was 1.20 per 100 person-years with the statin and 1.14 per 100 person-years with placebo, also a nonsignificant difference. The lack of protection associated with the active drug was consistent between men and women, across all fracture sites, and regardless of the participants’ fracture history. It also persisted through several sensitivity analyses, the investigators said (JAMA Intern. Med. 2014 Dec. 1 [doi:10.1001/jamainternmed.2014.6388]).
“Our study does not support the use of statins in doses used for cardiovascular disease prevention to reduce the risk of fracture,” the researchers noted.