Proton Pump Inhibitors May Increase Fracture Risk

On May 25, 2010, the U.S. Food and Drug Administration (FDA) announced that it would add safety information about the possible increased risk for hip, wrist, and spine fractures to the prescription and over-the-counter (OTC) labels for Proton Pump Inhibitors (PPIs), which include esomeprazole (Nexium), omeprazole (Prilosec, Zegerid), and lansoprazole (Prevacid).

PPIs treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Ironically, PPIs are commonly prescribed to treat side effects, such as dyspepsia or heartburn, commonly associated with bisphosphonates.

Dr. Amar R. Deshpande, an assistant professor of gastroenterology at the University of Miami Miller School of Medicine, said PPIs may disrupt the body's ability to absorb calcium, which, in turn, can increase the risk for fractures. He also believes this class of drugs is overused and often taken for too long.

The FDA is advising consumers to not stop taking PPIs until they have consulted with their doctors. However, patients should be aware of the increased risk for fractures. The highest risk was seen in people taking higher doses of PPIs, or among those who took them for a year or more. For people taking OTC proton pump inhibitors, the FDA said they should only be taken for 14 days to help ease frequent heartburn. If heartburn continues, people should see their doctor. Under no circumstances should over-the-counter PPIs be taken for more than three 14-day periods in a year, the agency said.

Strontium Ranelate Reduces Fracture Risk In The Elderly

According to a study by Ego Seeman et al., strontium ranelate produces an early and sustained reduction of both vertebral and nonvertebral fractures in women 80 years of age and older. More than 30% of all fragility fractures and 60% of hip fractures occur in women aged 80 and older, because of the high prevalence of osteoporosis and high incidence of falls. The aim of this study was to determine whether strontium ranelate, an agent that reduces the risk of vertebral and nonvertebral fractures in postmenopausal women >50 years of age, also reduces fractures in the elderly.

An analysis based on pooled data from two international, phase III, randomized, placebo-controlled, double-blind studies (the Spinal Osteoporosis Therapeutic Intervention [SOTI] and TReatment Of Peripheral OSteoporosis [TROPOS]) included 1488 women between 80 and 100 years of age followed for three years. Yearly spinal X-rays were performed in 895 patients. Only radiographically confirmed nonvertebral fractures were included.

The risk of vertebral, nonvertebral, and clinical (symptomatic vertebral and nonvertebral) fractures was reduced within one year by 59% (p = 0.002), 41% (p = 0.027), and 37% (p = 0.012), respectively. At the end of three years, vertebral, nonvertebral, and clinical fracture risks were reduced by 32% (p = 0.013), 31% (p =0.011), and 22% (p = 0.040), respectively. The medication was well tolerated, and the safety profile was similar to that in younger patients.

The authors concluded that treatment with strontium ranelate safely reduces the risk of vertebral and nonvertebral fractures in women with osteoporosis aged 80 and older. Even in the oldest old, it is not too late to reduce fracture risk.

J Bone Miner Res 2006;21:1113–1120. Published online on May 8, 2006; doi: 10.1359/JBMR.060404